Regulatory Affairs Manager jobs
West Pharma Quality Project Manager United States, Pennsylvania, West Whiteland Township
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In this role, the Quality Project Manager will support the standardization of QMS process and data management across the organization. This position will lead the development and deployment of quality maturity, QMS improvements and quality cost related measures, evaluations, performance, and initiatives. This position will coordinate activities associated with quality maturity including continuous improvement projects relating to sustaining engineering activities, development of new methods/processes for product evaluation and product development activities through a standardized approach. In addition, this position will deploy highly capable, predictive, effective, and efficient quality cost metrics for West Pharmaceuticals. This position will also be responsible for leading and executing cost improvement initiatives, follow up assessments and action oversight.
- Lead the initiative to standardize quality systems between multiple sites. Identify best practices and ensure roll out to relevant sites.
- Organize and generate detailed quality information reports to show trends and the impact of process improvements.
- Create repeatable methods to assess, measure and communicate the overall quality of a project and deliver key metrics to assess the overall improvement.
- Establish and lead cross functional quality related meetings to review and discuss performance, status and prompting necessary actions as required.
- Manage goals and metrics for Quality teams/initiatives to adequately monitor the overall effectiveness of the teams/initiatives.
- Work with project managers, engineering team, and platform management to develop plans to implement improvement projects.
- Ensures teams work closely with product development, supplier/contractors, design, quality, regulatory teams in order to establish standardized KPIs.
- Work within Quality or across West Divisions to triage Customer Operational difficulties, define root cause(s), and coordinate the implementation of corrective and preventive actions to preclude recurrence related to quality improvements and quality maturity.
- Manage or contribute to both corporate and facility driven initiatives intended to meet defined objectives.
- Support front room and or backroom responsibilities during external audits. Including post audit activities, if required.
- Responsible for assembling a project team, assigning individual responsibilities, identifying appropriate resources needed, and developing schedules to ensure timely completion of project.
- Record detailed customer requirements, constraints, and assumptions with stakeholders in order to establish the project deliverables.
- Responsible for project budget estimation, monitoring, and attainment throughout the project lifecycle.
- Ensure a common understanding by setting expectations in accordance with the project plan in order to align the stakeholders and team members.
- Lead the identification, assessment, monitoring, and closure of project risks throughout the project lifecycle.
- Manage changes to the project scope, project schedule, and project costs using appropriate verification techniques in order to keep the project plan accurate, updated, and reflective of authorized changes to facilitate customer acceptance.
- Responsible to improve team performance by building team cohesiveness, leading and motivating in order to facilitate cooperation, ensure project efficiency, and boost morale.
- Measure project performance using appropriate tools and techniques in order to monitor the progress of the project, identify and quantify any variances, perform any required corrective actions, and communicate to all stakeholders.
- May coordinate the activities of one or more exempt and/or non-exempt employees.
- All other duties as required.
- Bachelor's Degree in Science, Engineering or related field
- 8+ years of relevant work experience required
- 5+ years’ experience in pharmaceutical or medical device environment.
- 2+ years’ experience in a Quality role.
- ASQ CQE certification desirable.
- Deep knowledge of quality processes such as CAPA, complaint management, risk management, root cause analysis, statistical sampling plans, FMEA/Fault Tree Analysis, Design Optimization using DOE, Hardware Reliability, Software Reliability, and Design Controls including Design Verification/Validation.
- Knowledge of ISO 9001:2008, ISO 13485, 21 CFR 820, 21 CFR 210 & 211, cGMP, cGLP.
- Ability to manage direct report(s), work independently and in a team environment.
- Demonstrate innovativeness in tactical matters relating to proposing alternate solutions for process improvement.
- Experience in FDA regulated environment, pertinent to ISO 13485 is preferred.
- Experience with SAP is preferred.
- Support and contribute to Lean Sigma programs and activities towards delivery of the set target.
- Able to comply with the company’s safety policy at all times.
- Able to comply with the company’s quality policy at all times.
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Boston Scientific Manager Urology - Endourology Atlanta/ South GA United States, Florida
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About the Role
In this role, you’ll drive sales revenue beyond divisional goals while identifying and cultivating new business opportunities aligned with our strategic vision. You’ll collaborate across teams, maintain clinical expertise, and stay informed on products, programs, and market dynamics. Your ability to navigate both hospital and office-based settings with confidence and creativity will be key to overcoming challenges and delivering results.
Key Responsibilities
- Build trusted relationships with physicians and nurses through training, education, and promotion of cutting-edge technologies
- Cultivate connections across multiple stakeholders within the healthcare ecosystem
- Establish and maintain strategic relationships in key accounts, aligning actions with organizational goals
- Develop and execute quarterly business plans to meet revenue targets and business objectives
- Identify and pursue new business opportunities that reflect the company’s vision and priorities
- Collaborate with internal cross-functional teams to drive business outcomes
- Demonstrate clinical excellence in relevant disease states
- Stay current on Boston Scientific products, programs, and competitive landscape
- Adapt to change and thrive in a dynamic, fast-paced environment
- Manage territory with integrity and in compliance with our Code of Conduct
- Utilize tools such as Salesforce, Tableau, and other sales enablement platforms
- Conduct all sales activities in accordance with Travel & Entertainment (T&E) guidelines, AdvaMed policies, and company integrity standards
Required Qualifications
- Minimum 5 years of direct sales experience
- Bachelor’s degree
- Proven track record of sales success
- Strong oral and written communication skills
- High initiative and creativity; ability to meet deadlines with minimal supervision
- Willingness to travel 1–2 overnights per week
Preferred Qualifications
- Minimum 5 years of medical device sales experience
- Demonstrated leadership capabilities
- Experience selling in hospital, ambulatory surgery center (ASC), and office-based settings
- Familiarity with local Integrated Delivery Network (IDN) and Group Purchasing Organization (GPO) contracts
- Ability to present a compelling value proposition with both financial and clinical impact
- Experience selling disruptive technologies
- Background in consultative sales
- Proficiency with CRM tools
The anticipated annualized base amount or range for this full time position will be, plus variable compensation governed by the Sales Incentive Compensation Plan (which includes certain annual non-discretionary incentives based on predetermined objectives) as well as the value of core and optional benefits offered at BSC, which can be reviewed at www.bscbenefitsconnect.com. Actual compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, and other relevant business or organizational needs.
For MA positions:It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.
Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.
Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.
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West Pharma Senior Regulatory Affairs Specialist United States, Pennsylvania, West Whiteland Township
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The Sr. Specialist, Regulatory Affairs, Medical is responsible for influencing department regulatory processes and procedures, developing strategies, authoring, reviewing, and supporting global registrations, including Premarket Notifications, China NMPA Registrations, Technical Documentation for CE Marking, and technical packages. The Sr. Specialist ensures timely and high-quality execution of all regulatory deliverables. In addition, the Sr. Specialist mentors team members and ensures compliance with West Pharmaceutical Services, Inc. (West) and government requirements. This position includes supporting internal and external customer regulatory requests.
- Develop and implement medical device regulatory strategies for West’s administration and safety system product portfolio with an emphasis on gaining regional regulatory approval/clearance/licensure for medical devices in an efficient, compliant manner.
- Author and review US, EU, and additional international submissions with guidance for new products and product changes as required to ensure content accuracy, compliance with applicable regulations, and timely approvals for market release.
- Provide technical review of data and or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation.
- Provide leadership to cross functional teams for regulatory issues and questions.
- Compile and maintain regulatory documentation databases or systems as well as technical documentation required for new or modified products.
- Create documentation in response to customer regulatory requests which includes regulatory letters, technical packages, etc.
- Clearly and effectively communicate team/project progress/status, decisions, timelines, etc. to RA management, internal and external customers.
- Develop specific objectives and manage work assignments, with minimal guidance to achieve personal objectives in conformance with overall business goals
- Adhere to all applicable government and West regulations, practices, and procedures to maintain compliance
- Maintain working knowledge of computer software packages including MS Word, MS Excel, MS Teams, MS PowerPoint, Master Control, Adobe, SharePoint, and others as required
- Bachelor’s degree or equivalent experience is required
- Master’s degree or PhD in science, math, engineering, or related discipline preferred
- Minimum 5 years of relevant experience
- 2+ years of medical device regulatory experience preferred
- Experience with US FDA regulations (Title 21CFR820), EU MDD (93/42/EEC) and EU MDR (2017/745)
- History of successful international device registration,EU MDR technical documentation and/or US 510(K) authoring experience
- Advanced knowledge of ISO 13485
- Advanced knowledge of product life cycle, product development process, design control and change control
- Experience interacting with government agencies
- Excellent oral communication, technical writing, and decision-making skills
- Attention to detail with planning, time management and organizational skills
- Regulatory compliance competency including Quality Systems
- Experience with administration and safety systems preferred
- Ability to triage and manage work priorities and to follow established processes while identifying areas for process improvement.
- Ability to comprehend principles of math, science, engineering, and medical device use.
- Ability to handle technical reports, drawings, specifications, regulatory and quality documentation with a high degree of confidentiality.
- Ability to research, read, analyze, and interpret regulatory literature and documentation, regulations, technical standards, guidance documents, test reports, clinical/medical terminology, technical product information, and complex documents.
- Ability to review, collate, describe, and summarize scientific and technical data.
- Ability to organize complex information and combine pieces of information to form general rules or conclusions.
- Ability to utilize judgment and make decisions considering the relative risks and benefits of potential actions to choose the most appropriate one.
- Ability to assess, plan, schedule and manage multiple long-term and short-term projects, tasks, responsibilities and/or priorities in a concurrent fashion with several parallel deliverables and execute deliverables to time-line commitments.
- Ability to be an effective team member and work well with others in a team environment on cross-functional and/or matrix teams.
- Ability to be flexible with changing priorities and comply with constantly changing regulatory procedures.
- Ability to build strong relationships both internally and externally. Ability to work in a fast-paced environment.
- Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above.
- Ability to verbally communicate ideas and issues effectively to other team members and management.
- Ability to write and record data and information as required by procedures.
- Proficiency in the use of personal computers and computer programs, particularly, Microsoft Office Suite: Excel, Word, PowerPoint, and Adobe Acrobat (or equivalents if changed by the Company).
- Regulatory Affairs Certifications (RAC)-RAPS R.A.C certification(s) preferred
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Boston Scientific GI Manager - Endoscopy New York City United States, New York, New York
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Your responsibilities will include:
- Develop quarterly plans designed to achieve revenue targets
- Possess clinical excellence in respective disease states
- Build sustainable business relationships
- Drive sales revenue to exceed division priorities
- Define and develop new business opportunities that clearly reflect the company's vision and priorities
- Build and maintain sustainable strategic relationships in key accounts
- Stay current on BSC products / programs / competitive knowledge
- Commit to building trusting relationships with key physicians and nurses by training, educating, and selling them on our innovative technologies
- Uphold all the quality policies outlined within sales structure consistently and completely
- Demonstrate a primary commitment to patient safety and product quality
- Understand and comply with all regulations governing our work and comply 100% of the time with all BSC corporate policy and procedure initiatives
Required Qualifications:
- Bachelor's degree
- Minimum of 3+ years of relevant business experience
- Minimum of 3+ years of direct sales experience
- Documented sales success, falling within the top 10% performance in critical competencies
- Experience working in a fast-paced, complex work environment
Preferred Qualifications:
- Advanced degree
- Strong written and verbal communication skills
- Experience within the industry
- Sales management experience strongly preferred
- Field sales experience at Boston Scientific
Initial minimum compensation for this position is anticipated to start at $113,360.00 inclusive of annualized base salary, certain guarantees, and other non-discretionary performance-based incentives. Actual compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, and other relevant business considerations or organizational needs. Core and optional benefits offered at BSC can be reviewed at
It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.
Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.
Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.
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Boston Scientific Senior Regulatory Affairs Specialist - Endoscopy United States, Massachusetts, Marlborough
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At Boston Scientific, you’ll find purpose through your life’s work—improving lives with innovative medical solutions. Within our, we develop and deliver advanced technologies that diagnose and treat diseases of the digestive system, airway, and lungs. Our portfolio includes solutions in
We continue to invest in innovation across both established platforms and new pipeline development. As a, you will play a key role in supporting the global regulatory strategy for our Endoscopy product lines—from new product introductions to sustaining and post-market activities.
• Develop and implement regulatory strategies for new and modified medical devices
• Serve as a core team member on development projects, providing regulatory input throughout the product development lifecycle
• Draft and submit U.S. and EU regulatory filings for new and modified medical devices
• Review device labeling and advertising materials to ensure regulatory compliance and alignment with submission claims
• Review change notifications and conduct regulatory impact assessments for product and manufacturing changes
• Support associated global submissions in accordance with applicable regulations
• Serve as company representative in communications with regulatory agencies regarding submission strategy, testing requirements, and clarification or follow-up during review
• Support and maintain Boston Scientific's Quality initiatives in accordance with our Quality Policy
• Continuously identify and support opportunities for quality improvement across the organization
• Bachelor’s degree or equivalent work experience, preferably in a scientific or technical discipline
•in Regulatory Affairs within the medical device industry
• Strong working knowledge of
• General understanding of
• Familiarity with regulations related to the conduct of clinical trials
• Ability to manage multiple regulatory projects simultaneously
• Experience preparing and submitting, or international registrations
• Proficiency with Microsoft Office tools
• Strong analytical, research, and problem-solving skills
• Excellent written and oral communication, technical writing, and editing abilities
• Demonstrated ability to work independently with minimal supervision
Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).
Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).
For MA positions:It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.
Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.
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Boston Scientific Senior Innovation & Portfolio Strategy Manager United States, Minnesota
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Your responsibilities will include:
- Develop comprehensive plans to identify, evaluate, and recommend new and adjacent therapies in the exploratory pipeline to optimize the IO&E portfolio, including sizing market opportunities, competitive landscape, and understanding commercial implications through market research, clinical literature, metrics, coordination with customer interfacing teams and personal interaction with key customers
- Build and refine market models that incorporate dynamic inputs and assumptions, enabling accurate forecasting and scenario planning in partnership with Marketing Strategy, Finance and R&D
- Develop and implement comprehensive strategies and business cases for market entry and expansion, considering risk and return factors
- Partner with Upstream Marketing Leads and cross-functional partners, (R&D, Clinical, Market Access, Regulatory, Finance, Strategy, Business Development, and/or other functions as appropriate) to ensure early-stage NPD investments reflect a focused strategy for new therapies and adjacent markets that are supported by clear strategic frameworks and financial rationale
- Drive and conduct “Voice of Customer” (VOC) and “Voice of Business” (VOB) work where applicable to inform market and business needs while investigating new strategic initiatives
- Identify, track and provide updates to senior leadership on key competitive initiatives to support strategic decision making; conduct and/or direct vendors in market analysis and research
- Strong project management and alignment, including communication of timelines and collaborating with internal and external stakeholders in a matrix environment to proactively remove barriers for project completion
- Lead long range portfolio planning process for all Interventional Oncology & Embolization businesses
- Exhibit professional maturity and help to foster an open, challenging, stimulating and positive environment that enables colleagues to be their best
- 5-10% travel as needed for projects
Required qualifications:
- Bachelor’s degree (marketing, engineering or healthcare preferred)
- 5+ years prior experience in upstream marketing, product management, business strategy/analytics or strategic marketing OR at least 3-5 years in consulting or business development within MedTech or Pharma industry
- Demonstrated expertise in market modeling, including the ability to integrate epidemiology data, disease state insights, and market segmentation frameworks to build models that reflect complex market conditions through dynamic inputs and assumptions (e.g., evolving clinical guidelines, competitive entries, reimbursement shifts, and technology adoption curves).
- Strong analytical, quantitative, financial modeling (e.g. Excel) and strategic thinking skills
- Ability to work independently and deliver results including distilling complicated data or concepts down to simplified executive summaries
- Proven history of identifying and executing new product investments
- Demonstrated success managing complex projects, incorporating diverse needs from numerous stakeholders and delivering on commitments with agility and creativity
- Must have held roles that have consistent exposure to Senior Leadership on a regular basis. Ability to influence leadership and key stakeholders through excellent communication (verbal and written) and interpersonal skills and creating compelling, cohesive, and succinct presentations
Preferred qualifications:
- MBA or advanced degree
- Healthcare or medical device marketing experience in Oncology, with demonstrated ability to develop deep clinical and commercial expertise in medical device therapies and products
- Competencies within reimbursement and coding. Ability to understand, analyze and synthesize multiple data sources including claims (e.g. DHC, IQVIA) and diverse 3rd party data
- KOL engagement and experience managing multiple physician collaborators
- Ability to work in a fast-paced environment as an individual contributor and effectively in a team-based environment while managing multiple priorities
- Prior strategic planning and product development experience
- Experience with Snowflake, Tableau, PowerBI, and Alteryx a plus
Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).
Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).
For MA positions:It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.
Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.
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West Pharma Sr Manager Operational Excellence United States, North Carolina
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In this role you will coordinate business unit lean savings, goals and objectives through the use of statistical techniques by planning, scheduling, and executing process projects. You will communicate project status, and define and shape strategic planning efforts, including critical goal and objective development that identifies and improves critical processes necessary to achieve annual targets, including waste reduction to drive technical and operational improvement. This role will focus on coordinating, managing, and driving all transformation initiatives across site, ensuring alignment with both site’s and operational goals and the corporate stakeholders’ broader strategic objectives.
- Oversee the planning, execution, and delivery of all transformation projects, ensuring they are completed on time, with scope and within budget.
- Establish clear metrics and KPI’s for each transformation initiative, regularly tracking and reporting on progress to SLT and key stakeholders.
- Participate in the development and support of the West Business System (WBS), with the goal of sustaining operational standards on the site.
- Develop and communicate a comprehensive transformation strategy that aligns with the site growth targets, technical & operational capability imperatives, operational excellence objectives and the Operating Units vision.
- Provide thought leadership and direction for all transformation activities, ensuring they are prioritized, scheduled, and executed effectively.
- Create strategic plans to eliminate waste within the business unit by utilizing lean processes, key performance indicators, metrics, cost savings, best demonstrated practices and enterprise resource management.
- Create and execute a robust change management framework that prepares the site and its employees for upcoming changes, minimizes resistance, and maximizes adoption of new processes and technologies.
- Ensures that all transformation initiatives are supported by effective communication plans that keep all stakeholders informed and engaged.
- Develop robust, capable systems necessary to achieve the strategic goals and objectives and drive excellence through the manufacturing operations; assure that production processes are repeatable and capable of meeting specifications, by ensuring the consistent and uniform application of OPEX tools.
- Provide leadership on lean thinking and lean processes to ensure established goals and objectives are met and provide methods to monitor processes to assure they remain in control.
- Assist in the training and guidance for lean champions and team members to develop and implement Lean action plans and transfer lean initiatives to other West plants.
- Bachelor’s in engineering, Statistics or recognized equivalent required
- Master’s Degree in related field preferred
- Minimum 10 years (Sr Mgr) in related field required
- At least 5 years of experience in a manufacturing/production environment required
- Must possess a Six Sigma Green Belt certification and have at least 5 years of experience demonstrating and using Six Sigma/Lean tools and methodologies required
- Medical Device industry experience preferred
- Must have good interpersonal/leadership skills and be able to interface with all departments and team member levels.
- Must have excellent organizational, interpersonal and problem-solving skills and be able to interface with employees at all levels of the organization.
- Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description.
- Safely work in construction environments
- Noise level in the work environment while on the production floor is usually moderate to loud. Hearing protection is required.
- Must follow and comply with Plant’s Dress and Hygiene Code (SOI)
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In this role, the Quality Project Manager will support the standardization of QMS process and data management across the organization. This position will lead the development and deployment of quality maturity, QMS improvements and quality cost related measures, evaluations, performance, and initiatives. This position will coordinate activities associated with quality maturity including continuous improvement projects relating to sustaining engineering activities, development of new methods/processes for product evaluation and product development activities through a standardized approach. In addition, this position will deploy highly capable, predictive, effective, and efficient quality cost metrics for West Pharmaceuticals. This position will also be responsible for leading and executing cost improvement initiatives, follow up assessments and action oversight.
- Lead the initiative to standardize quality systems between multiple sites. Identify best practices and ensure roll out to relevant sites.
- Organize and generate detailed quality information reports to show trends and the impact of process improvements.
- Create repeatable methods to assess, measure and communicate the overall quality of a project and deliver key metrics to assess the overall improvement.
- Establish and lead cross functional quality related meetings to review and discuss performance, status and prompting necessary actions as required.
- Manage goals and metrics for Quality teams/initiatives to adequately monitor the overall effectiveness of the teams/initiatives.
- Work with project managers, engineering team, and platform management to develop plans to implement improvement projects.
- Ensures teams work closely with product development, supplier/contractors, design, quality, regulatory teams in order to establish standardized KPIs.
- Work within Quality or across West Divisions to triage Customer Operational difficulties, define root cause(s), and coordinate the implementation of corrective and preventive actions to preclude recurrence related to quality improvements and quality maturity.
- Manage or contribute to both corporate and facility driven initiatives intended to meet defined objectives.
- Support front room and or backroom responsibilities during external audits. Including post audit activities, if required.
- Responsible for assembling a project team, assigning individual responsibilities, identifying appropriate resources needed, and developing schedules to ensure timely completion of project.
- Record detailed customer requirements, constraints, and assumptions with stakeholders in order to establish the project deliverables.
- Responsible for project budget estimation, monitoring, and attainment throughout the project lifecycle.
- Ensure a common understanding by setting expectations in accordance with the project plan in order to align the stakeholders and team members.
- Lead the identification, assessment, monitoring, and closure of project risks throughout the project lifecycle.
- Manage changes to the project scope, project schedule, and project costs using appropriate verification techniques in order to keep the project plan accurate, updated, and reflective of authorized changes to facilitate customer acceptance.
- Responsible to improve team performance by building team cohesiveness, leading and motivating in order to facilitate cooperation, ensure project efficiency, and boost morale.
- Measure project performance using appropriate tools and techniques in order to monitor the progress of the project, identify and quantify any variances, perform any required corrective actions, and communicate to all stakeholders.
- May coordinate the activities of one or more exempt and/or non-exempt employees.
- All other duties as required.
- Bachelor's Degree in Science, Engineering or related field
- 8+ years of relevant work experience required
- 5+ years’ experience in pharmaceutical or medical device environment.
- 2+ years’ experience in a Quality role.
- ASQ CQE certification desirable.
- Deep knowledge of quality processes such as CAPA, complaint management, risk management, root cause analysis, statistical sampling plans, FMEA/Fault Tree Analysis, Design Optimization using DOE, Hardware Reliability, Software Reliability, and Design Controls including Design Verification/Validation.
- Knowledge of ISO 9001:2008, ISO 13485, 21 CFR 820, 21 CFR 210 & 211, cGMP, cGLP.
- Ability to manage direct report(s), work independently and in a team environment.
- Demonstrate innovativeness in tactical matters relating to proposing alternate solutions for process improvement.
- Experience in FDA regulated environment, pertinent to ISO 13485 is preferred.
- Experience with SAP is preferred.
- Support and contribute to Lean Sigma programs and activities towards delivery of the set target.
- Able to comply with the company’s safety policy at all times.
- Able to comply with the company’s quality policy at all times.
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