Supplier Quality Engineer 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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MongoDB Senior Software Engineer Atlas Clusters Security United States, New York, New York
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- Build and design new features for MongoDB Atlas
- Contribute to and lead complex technical projects
- Work closely with product and design teams, considering the user’s perspective while building technical solutions
- Work with customers and support engineers to fix issues
- Collaborate with team members to develop our codebase, best practices, and design principles
- Learn from and mentor other team members
- Has at least 5 years of professional software development experience
- Is skilled at writing large-scale, distributed backend systems in a compiled language (Java, C#, Go, etc.)
- Is comfortable working across the stack of a modern web application (e.g. React, TypeScript)
- Has experience with at least one major cloud provider technology (AWS, Azure, GCP)
- Has led the launch of a new module and maintained it in production
- Is eager to solve tough problems
- Has excellent communication skills
- Is curious, collaborative, and motivated
- In 3 months, you'll have shipped code into production and collaborated with the team to solve tough problems
- In 6 months, you'll have contributed to a large project
- In 12 months, you'll have designed new features, led development work, and become a go-to expert on parts of the system
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West Pharma Senior Process Engineer United States, Pennsylvania
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- Initiate, lead and coordinate improvements of existing processes globally on quality, service, HSE and cost within the standard known/approved process frame and using best practice knowledge
- Strongly support the implementation / roll-out of automation and new innovative processes and technologies in joint cooperation with the automation, engineering- and quality assurance teams and the plants.
- Manage the development of robust process for final industrial production in targeted plants.
- Assess current process status in all relevant West locations globally, define best practices, perform a gap analysis and manage the harmonization of this best practice to all sites involved.
- Engage in solutioning product or process related issues as needed.
- Support the introduction, start-up and validation of new equipment in the local sites.
- Support process or technology or product transfer projects between plants from a process stand-point.
- Evaluate and approve all change requests globally.
- Utilize six sigma tools in minimizing process variation and improving the quality of product produced.
- Bachelor's or Master's Degree in Engineering or another scientific area or equivalent experience required
- Minimum 3 years experience in a similar position within the manufacturing industry required
- Experience in Project Management preferred
- Good knowledge of LEAN and Six Sigma manufacturing principles (Green Belt certification)
- Knowledge of MS Office, statistical tools and Minitab
- cGMP knowledge
- Fluent English and German skills
- Self motivated, result- and solution-oriented personality
- Excellent communication skills
- Ability to successfully collaborate with teams across different countries and organizational levels
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Boston Scientific Quality Engineer II United States, Minnesota
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About the Role:
In this dynamic production environment, they have the opportunities to develop, establish and maintain quality engineering methodologies, systems, and practices. Serving as representatives of the Quality organization, they will improve awareness, visibility and communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities.
Your Responsibilities Include:
- Partners with Manufacturing Engineering and Production core team members for daily manufacturing line support decisions and practices.
- Collaborates with cross-functional team to evaluate manufacturing results, assist defect detection, primary cause identification, and understanding corrective and preventative actions.
- Identifies and implements effective process control systems to support the development, qualification, validation and verification to meet or exceed internal, external, and regulatory requirements.
- Supports a culture of continuous improvement by advancing improvements to existing processes and controls.
- Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.
- Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Broadly engages with production teams across all shifts to develop and support solutions to improve outgoing quality.
- Provide task direction, coaching, and mentorship for technician team members.
- Participate in team decision-making and display team problem-solving/communication skills.
What We’re Looking For:Required Qualifications:
- Bachelor’s degree in engineering, technology, mathematics, or related science
- 2+ years of relevant experience in a regulated industry
- Strong verbal and written communications skills; Good documentation practices
- Works effectively in a Controlled Environment Area (CEA) manufacturing environment
- Self-starter with a proven ability to successfully work with minimal supervision
- Knowledge of basic Quality Management Systems
- Proficient with Microsoft Office tools (Word, Excel, PowerPoint, Outlook)
Preferred Qualifications:
- Medical device experience
- Comfortable with utilizing analytical equipment (including microscopes)
- Strong analytical skills, problem solving, and statistical analysis (Excel, Minitab)
- Experience with the following disciplines: manufacturing/process engineering, post-market complaints, supplier quality, CAPA, risk management
- Experience running/owning nonconforming event risk assessments and investigations
- Proficient using manufacturing control software (various MES, MasterControl, etc.)
- Project management experience
Maximum Salary: $ 132000
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.
Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.
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Boston Scientific Senior Packaging Engineer United States, Minnesota
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Your responsibilities include:
- Perform all aspects of the monthly financial close including generation of monthly and quarterly management reporting and variance/trend analysis
- Supports the annual planning process for the functional areas of responsibility including coordinating with the various functional groups to develop operating expense budgets and providing analytical support to identify key business drivers
- Analysis and submission of functional budgets
- Support decision-making process to enable profitable growth
- Support regular and adhoc reporting and presentations to management
- Identify and drive cost saving opportunities across the SG&A functions
- Quickly respond to numerous ad hoc queries from internal customers (including Senior Management)
Minimum Qualifications:
- Bachelor’s degree in Finance or Accounting
- 5+ years of relevant FP&A experience
- MS Excel and PowerPoint required, financial tools (Hyperion (Oracle), SAP) preferred
- Excellent oral and written communication skills
- Strong financial analysis, communication, organizational and prioritization skills
- Strong attention to detail and data accuracy
Preferred Qualifications:
- Ability to multi-task and set priorities/execute in a high-paced organization
- Ability to work in a dynamic environment, adhere to tight deadlines
- Team orientated
- Must have a process improvement mindset and strong problem-solving skills
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 Design Quality Cybersecurity Engineer United States, Minnesota
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Your responsibilities will include:
- Interpret and apply relevant cybersecurity standards and regulations (e.g., FDA/CMDE/MDCG Cybersecurity Guidance, IEC 62443, ISO 14971, HIPAA, GDPR) to ensure product compliance.
- Stay current with emerging regulations and standards related to medical device security (e.g., FDA Premarket Guidance, Post-market Cybersecurity Guidance).
- Collaborate with product development teams to embed security controls throughout the design, development, and maintenance phases.
- Self-motivated with a passion for solving problems and a bias for action.
- Ensure that medical device security engineering activities and deliverables (e.g., threat models, security risk assessments, security requirements, security test plans/protocols/reports, SBOM, post-market vulnerability management plans and reports, and cybersecurity labeling) comply with Boston Scientific's global quality system requirements and procedures.
- Collaborate with team on product security needs and requirements; review product security architectures and design specifications.
- Collaborate in planning of software verification and validation strategies.
- Review vulnerability assessments, fuzzing and penetration testing to identify and mitigate risks.
- Ensure continued consistent best practices and processes for secure coding, configuration management, and patching.
- Develop and implement risk mitigation strategies and maintain risk management documentation consistent across the ICTx portfolio.
- Oversee and enhance incident response plans and processes, ensuring rapid and effective resolution of security incidents.
- Drive continuous improvement of vulnerability management, including the evaluation and deployment of necessary patches or updates.
- Work closely with internal stakeholders (Software Development, R&D, Regulatory, IT, etc.) to align on security goals and requirements.
- Participate in internal and external audits, and address findings related to cybersecurity design and risk management processes.
What we’re looking for in you:
Required qualifications
- Bachelor’s degree in Cybersecurity, Computer Science, Computer Engineering, or a related field and 5+ years of experience in cybersecurity engineering, with a focus on product development and risk management or Master’s degree in Cybersecurity, Computer Science, Computer Engineering, or a related field and 3+ years of experience in cybersecurity engineering, with a focus on product development and risk management
- Proven experience leading security design and architecture reviews for complex, embedded medical devices or similar technologies.
- Demonstrated track record of creating and executing security risk assessments and mitigation strategies.
- In-depth understanding of cybersecurity frameworks (e.g., NIST Cybersecurity Framework).
- Understanding of privacy regulations (HIPAA, GDPR) and their intersection with medical device cybersecurity.
- Strong leadership, decision-making, and team-building capabilities.
- Excellent written and verbal communication skills for interfacing with technical teams, stakeholders, and executive leadership.
- Ability to work collaboratively across multidisciplinary teams, bridging gaps between technical, regulatory, and business functions.
Preferred qualifications
- 5+ years of experience working in the medical device industry or a similarly regulated environment; security architecture or medical device administration experience in healthcare settings is also a plus.
- Hands-on experience with secure coding practices, vulnerability scanning tools, fuzzing, and penetration testing methodologies.
- Knowledge of embedded systems security, wireless communications, network protocols, and PKI.
- Familiarity with FDA regulations and guidance documents for medical devices (e.g., 21 CFR Part 820).
- Working knowledge of SW96/TIR57/TIR97, IEC 62304 (software lifecycle), IEC 60601 (electrical safety), and ISO 14971 (risk management).
- Experience supporting VA Handbook 6500 compliance and ISO/IEC 27001 certification.
- Relevant certifications (e.g., GIAC, OffSec, CISSP, CISM, CRISC) are a plus.
Maximum Salary: $ 156900
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.
Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.
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Boston Scientific Quality Tech II - 1st Shift United States, Minnesota
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Applicants must be authorized to work in the United States without the need for employer sponsorship, now or in the future.
- Establishing category strategies that result in a sustainable competitive advantage.
- Managing strategic supplier relationships in line with company and category expectations
- Negotiating and executing contracts that deliver the best outcomes for Boston Scientific
- Driving sustained year-over-year value improvement related to quality, service, and cost.
- Defining technology roadmaps that align with long-term product and patient needs.
- Collaborating with Supplier Engineering to develop should-cost models.
- Gathering and analyzing market intelligence to report on trends, risks, etc.
- Identifying market and sourcing risks; work with stakeholders to define and execute mitigation plans.
- Providing key data analytics and reporting to support category and supplier strategies
- Supporting the broader sourcing team with data analytics and supplier communications
- Providing source selection recommendations for new products that align with the category strategy.
- Driving early supplier involvement with R&D to achieve development objectives, timelines, and reduce costs.
- Facilitating supplier business reviews; attend on-site supplier visits for assessments, negotiations, business reviews, etc.
- Facilitating the identification and evaluation of new materials and technologies
- Identifying and rationalizing insourcing vs. outsourcing opportunities
- Supporting or leading business process improvement projects
- Providing escalation support to site purchasing teams as required
- Bachelor’s degree in Supply Chain, Engineering, Business, or a related field
- Experience in Sourcing, Supply Chain Management, or Supplier Relationship Management
- Proficient with MS Office Excel and other applications (i.e., Word, PowerPoint, MS Project etc.)
- Ability to travel up to 20%.
- Minimum 2 years of experience in Sourcing, Supply Chain Management, or Supplier Relationship Management
- Master’s Degree or professional certification (i.e., CPSM, CPIM, CSCP, PMP, Lean Six Sigma, etc.)
- Experience sourcing for electronic components or medical devices.
- Experience working in medical device or similar regulated industry.
- Strong data analysis skills, with ability to translate data into strategy
- Ability to take direction and coaching from mentors
- Strong decision-making and negotiation skills, ability to influence internal and external teams.
- Ability to work independently and collaborate with cross-functional teams to complete projects.
- Strong interpersonal skills, with ability to communicate effectively with individuals on all levels.
- Strong critical thinking and analytical skills: process and results-oriented
- Detail oriented with strong organizational skills; ability to multi-task and prioritize competing responsibilities effectively.
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.
These jobs might be a good fit
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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.
These jobs might be a good fit
