דרושים Senior Engineer Quality Systems ב-West Pharma ב-United States, Scottsdale

Senior Engineer, Quality Systems supports and executes the effective development, implementation, and continuity of the Quality Management System (QMS) at a site and business unit level, ensuring compliance with ISO 13485, EUMDR, GxP, and other regulatory requirements. This role encompasses responsibilities such as supporting and managing the CAPA program(s), non-conformance process(es), management review(s), audit(s), document control, etc. Sr. Engineer, Quality Systems collaborates with business leaders to create and maintain efficient quality system programs, driving change management and continuous improvement initiatives. Provide training on quality best practices and utilize ISO 14971 risk management techniques to ensure alignment with quality requirements. As a key communicator, this position demands excellent written and verbal skills to engage confidently across organizational levels. The role requires meticulous documentation practices, adherence to good manufacturing practices, and active participation in continuous improvement projects, ensuring a safe work environment and compliance with company policies and regulatory standards. This is an onsite role based in Scottsdale AZ.

• Contribute to the enhancement of local site and business unit level QMS to ensure strict compliance with FDA 21CFR Part 820, ISO 13485, EUMDR, GxP, and relevant regulatory requirements.
• Collaborate with departments and sister-sites to set and maintain quality objectives, metrics, and programs.
• Coordinate and prepare critical information for Management Reviews and safeguard key performance metrics (KPIs) within compliance frameworks.
• Manage the non-conformance system to guarantee comprehensive documentation and resolution of incidents.
• Support internal and external audits by regulatory bodies and clients, ensuring compliance with established quality standards.
• Drive effective change management processes at a site and business unit level, assessing product/process modifications against quality requirements.
• Train staff to procedures and quality best practices, fostering an organization-wide quality-centric culture.
• Utilize ISO 14971 risk management techniques to mitigate risks in product development and manufacturing processes.
• Develop and uphold robust procedures for quality system elements per ISO 13485.
• Identify and propose process improvements to enhance quality and operational efficiency.
• Oversee the Corrective and Preventive Action (CAPA) process, ensuring thorough investigation and resolution through the CAPA Review Board (CRB).
• Facilitate root cause analysis, implementing CAPA to address quality issues and support continuous improvement initiatives.
• Maintain a high level of scrutiny in reviewing and approving CAPA investigations and extensions.
• Provide detailed reports and insights on QMS performance to senior management.
• Align activities with regulatory guidelines such as FDA 21CFR Part 820, ISO 13485, GxPs, and ISO 14971.
• Adhere to all regulations, policies, and safety protocols consistently.
• Maintain punctuality and reliable attendance, adhering to a customer service-oriented approach.
• Keep a clean, orderly, and safe working environment.

• Education: Bachelor's Degree in Engineering or Science or equivalent experience required
• Work Experience: 5-8yrs of experience in a Quality Management System (QMS) or Quality Assurance or Quality Engineering role(s) specifically within medical devices is essential (medical device manufacturing preferred).
• Proven track record in handling Quality System Procedure(s), CAPA, non-conformance, and audits as part of a QMS. Proficient knowledge of ISO 13485, ISO 14971, FDA 21CFR Part 820, and EUMDR.
• Regulatory and QMS Knowledge: Comprehensive understanding of ISO 13485, ISO 14971, FDA 21CFR Part 820, and EUMDR. Comprehensive understanding of ISO 13485, ISO 14971, FDA 21CFR Part 820, and EUMDR.
• Skills and Competencies: Strong analytical and problem-solving skills, particularly in non-conformance, CAPA, and root-cause analysis. Excellent organizational skills and the ability to communicate effectively at various levels of the organization. Proficiency in working within a team-oriented environment with strong interpersonal capabilities.

• Technical Proficiency: Demonstrated expertise in computer skills and familiarity with quality-related software and tools including EDMS and SAP.
• Deadline & Project Management: Proven ability to efficiently meet deadlines in a fast-paced, changing environment.
• Problem-Solving Expertise: Strong problem-solving skills with knowledge of Lean Six Sigma methodologies being advantageous.
• Root Cause Analysis: Proficient in Root Cause Analysis methodologies such as A3, 5 Why’s, 6M’s, 8D’s, and DMAIC.
• Regulatory Knowledge: In-depth understanding of Medical Device Regulatory Requirements and Standards, including 21 CFR Part 820, EU/MDR, ISO 13485, ISO 14791, GMPs, and GDP.
• Analytical Skills: Strong data analysis skills with knowledge of statistical requirements for sampling plans (application of Minitab statistical software, preferred).
• Organizational Skills: Highly organized, detail-oriented, and self-motivated with project management expertise.
• Communication Skills: Experienced in report writing with clear and effective communication, and experience working with manufacturing operations. Ability to communicate with and to multiple levels and positions within the organization.
• Validation Expertise: Skilled in validation processes and experienced with manufacturing operations.
• Collaborative & Independent Work: Ability to work effectively both individually and as part of a team, with the capability to engage and leverage others to accomplish projects.
• Procedural Awareness: Ability to develop, understand, and adhere to all relevant standard operating procedures as per company policies and regulations related to this role

Certification in Quality Engineering (CQE) or as a Certified Quality Auditor (CQA) is preferred.

• The Senior Procurement Associate serves as a strategic partner to the Site’s Operations Management Team, focusing on key risk mitigation and procurement initiatives to create total cost value.
• This role involves leading site-specific supplier negotiations, supplier development, and project management facilitation for supplier-related projects.
• The position requires liaising between the site and global strategic sourcing, promoting supplier improvements and cost efficiencies, and supporting site goals linked to global strategic sourcing objectives.
• This position will be reporting to the Senior Site Procurement Manager.

• Lead the end-to-end procurement processes across assigned sites, including supplier selection, negotiation, contracting, and implementation for locally managed projects and services.
• Develop and execute site-specific sourcing strategies and plans to ensure alignment with procurement goals.
• Serve as the primary procurement liaison between site stakeholders and Global Strategic Sourcing teams, ensuring effective communication of global sourcing initiatives.
• Cultivate strong relationships with key suppliers and internal stakeholders to drive continuous improvement, innovation, and cost efficiency.
• Implement and manage a supplier scorecarding process to ensure supplier performance, compliance, and service-level delivery.
• Mitigate supplier and procurement risks affecting site operations through proactive risk management.
• Provide in-depth spend analysis and initiate requests for competitive bids to enhance procurement decision-making.
• Key Performance indicators will include and not be limited to metrics such as savings, payment terms, spend management, compliance, supplier relationship, risk mitigation and aligning to the procurement goals set forth annually.
• Collaborate cross functionally with Quality, Finance, HSE, or others to ensure procurement activities align with site-level objectives.
• Act as an escalation point and provide support or resolution in addressing site-specific direct material issues, collaborating with relevant teams to execute the strategies and drive overall site improvements.
• Adhering and understanding the West policies to support operational excellence.
• Other duties as assigned.

• Bachelor’s degree or related equivalent work experience in Procurement, Supply Chain, Manufacturing, Engineering, Finance, or related field.

• 5 years related business experience required or master’s degree with 4+ years of experience.

• MBA and Six Sigma Green Belt preferred.
• Medical device manufacturing experience preferred.
• Certification from the Institute of Supply Management or related preferred.
• Proficient in Microsoft Office, PowerPoint, MS Project, and systems like SAP, Spend Analyzer, and Agile.
• Strong analytical skills with the ability to interpret complex business situations and resolve intricate supply chain issues.
• Excellent organizational skills enabling effective task prioritization and delegation with minimal supervision.
• Outstanding communication and presentation skills, with the ability to engage effectively at all organizational levels.
• Proven ability to lead cross-functional teams, influence, motivate, and mentor colleagues.
• Strong decision-making skills and attention to detail.
• Demonstrated expertise in supply chain management, strategic sourcing, inventory management, and contract management.
• Familiarity with and adherence to company procurement, safety, quality, and standard operating procedures.
• Self-driven with the capability to motivate and mentor others, ensuring effective collaboration and task execution.
• Strong attention to detail paired with excellent time management and versatility in handling multiple tasks.
• Comprehensive understanding of business operations and the ability to ensure effective decision-making in a procurement context.

In this role, the R&D Laboratory Technician will work under the direction of the R&D Lab Supervisor to support the R&D lab team with test sample builds, engineering and design verification testing activities, and have responsibilities associated with lab management, inventory management, and equipment qualifications. The individual will bring excellent analytical, technical, and organizational talent to the execution of development projects at West.

• Performs and documents engineering and verification testing activities for a product (or product family).
• Proficient in laboratory test equipment operation and accustomed to using current Good Documentation Practices (GDP).
• Assists the engineering team in the development of test methods, work instructions, and other documentation as required.
• Prepares test samples according to work instructions and procedures for engineering and verification testing.
• Follows protocols required for Engineering Testing, Design Verification Testing, Test Method Validation, and Equipment Qualification.
• Participates in the execution of Gage R&R and qualification of engineering test fixtures, assembly fixtures, test methods, and assembly methods used in the development process.
• Manages component inventory for test samples. Performs incoming inspection and receiving activities for new inventory lot creation. Creates necessary documentation in support of assigned activities in compliance with West QMS
• Manages the calibration status of laboratory tools and equipment, communicates with calibration vendors to get equipment calibrated, reviews calibration certificates, and ensures proper storage of all associated calibration documentation.
• Performs regularly scheduled general preventative maintenance activities on laboratory tools, equipment, and machinery.
• Identifies and resolves potential safety hazards. Maintains a clean, neat, and safe work environment.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Performs other duties as assigned based on business needs.

• Technical experience performing testing in medical device industry.
• Uses critical thinking to make decisions and operate independently with minimal manager supervision.
• Highly organized person whom demonstrates initiative and commitment to quality in all tasks.
• Proficient in MS Office suite including PowerPoint, Word, Excel and Outlook.
• Excellent oral and written communication skills.

• High School Diploma required.
• Associate's Degree Technical Field (Chemistry/Biology/Engineering) preferred

• Experience: 3+ years of experience in a laboratory environment.

• Must be able to work assigned shift(s) with overtime as required to complete assignments if necessary.
• Sitting and/or standing for extended periods may occur as well as getting to and from offices and building sites.
• Potential handling of biohazard material and components.
• Provide a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.

In this role, you will work under the direction of the Complaints Quality Manager to support activities related to product root-cause failure investigations on electro-mechanical drug delivery devices in a biohazard laboratory. You will additionally drive lean initiatives on the investigation process, manage communication with internal and external customers, and train team members on new devices.

• Is proficient in the use and maintenance of laboratory test equipment necessary for conducting root-cause investigations; such as Instron, CT scanner, oscilloscope, power supply, multi-meter, microscopes.

• Is proficient in the process of conducting root cause investigations of R&D or returned field units.

• Utilizes on the job experience, critical thinking skills, and root cause analysis methodologies to assist lab technicians with atypical and/or complex root cause determination.

• Has effective technical writing skills and is able to communicate findings in a technical, concise, and effective manner with little to no assistance. Documents investigations reports per procedures.

• Assists the Complaints Quality Manager with:

  • Review and approval of investigation reports

  • Training technicians on the investigation processes and use of laboratory equipment.

  • Performing daily, weekly, and/or monthly tracking and trending activities related to complaints and other lab metrics.

  • New customer onboarding

  • Complaint-handling process improvements / lean initiatives.

• Contributes to the design and development of new tests and debugging methods.

• Identifies critical product issues. Assists with Issue Reviews and Corrective & Preventive Actions (CAPAs) when necessary. Contacts appropriate support and/or management to ensure issues are reported and resolved.

• Creates and maintains a clean, neat, and safe work environment through identifying and resolving potential safety hazards.

• Facilitates teamwork and collaboration between departments to maximize processes and resolve problems.

• Demonstrates a “Customer Service” approach to all activities and assignments.

• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.

• Complies with the company’s safety and quality policies at all times; including proper handling of biohazard materials and components.

• Exhibits regular, reliable, punctual and predictable attendance.

• Education: Bachelor's in Science or Engineering

• Experience: 3-5 years of experience

• Experience in conducting root cause investigations of field units.
• Experience in laboratory test equipment operation and maintenance such as Instron, CT scanner, oscilloscope, power supply, multi-meter, and microscopes.
• Background in medical device or pharmaceutical industry.
• Knowledge of lean manufacturing and operational excellence concepts.

• Demonstrated ability to:
  • Prioritize and complete multiple tasks. Has effective time management skills and can easily adapt to changes in priorities; needs little to no assistance in determining priorities and deliverables.
  • Understand and communicate technical ideas and concepts with technical and non-technical audiences (writtenand verbal)

• Cultivate a positive working relationship with the West Customer base via supporting validation in design and development, agreeing specification, execution of manufacturing and programs in line with agreed standards. All the while ensuring that the West’s product quality and reliability meets or exceeds customers’ expectations.
• Accountable for the development of the quality assurance plans and systems to ensure commercial manufacturing, development programs and NPI programs remain compliant with all applicable regulations and guidelines.
• Oversee regulatory agency interaction related to compliance to local and regional guidelines/ regulations.
• Develop strong internal and external relationships with regulatory bodies and authorities.
• Develop and champion a quality/ patient first organizational culture that promotes behaviors that lead to superior quality and business performance and enterprise excellence.
• Responsible for ensuring QA resources have the adequate training, education, competency, and experience to perform their GMP related job functions effectively. Ensure sufficient support in place to support programs and flawless transition into Operations.
• Responsible for developing a culture of risk activities in the development and maintenance of product/ process risk and hazard analysis
• Coach, mentor and lead highly dynamic team members to help achieved the requirements of this position as well as the individual career goals of team members.
• Responsible and accountable for quality departmental budget.
• Accountable for the final disposition of product and for the decision on final batch release of medical device components, sub-assemblies and finished medical devices.
• Play a role as a key contributor to documentation updating, including leading any updates.
• Participate in and drive compliance to global harmonization initiatives.
• Responsible for quality data trending e.g., CAPA, Deviations, Customer Complaints, Product Quality KPI's and Change Requests and driving quality improvements.
• Ensures all Quality and Regulatory correspondence (internal and external) is aligned and compliant with West policies and guidance.
• Acts as a mentor and coach to the business with respect to Quality and Regulatory knowledge.
• Fosters and encourages shared learning’s across West e.g., system and technology best practices and harmonization / standardization of West Procedures and practices.
• Perform additional duties at the request of the direct supervisor.

• Bachelor's Degree Preferably in engineering, preferred disciplines could include mechanical engineering, chemical engineering, manufacturing engineering, industrial engineering; required

• Minimum 10 years required and
• Previous leadership experience, preferably managing remote employees. preferred and
• Experience in regulated industry such as pharmaceutical and medical device. preferred and
• Project Management experience preferred

• Strong knowledge and understanding of FDA’s 21 CFR Part 820, ISO13485, ISO9001, and other international regulations
• Familiarity with document management databases, particularly MasterControls and SAP.
• Proven ability to manage multiple priorities, drive projects to completion and meet internal customer expectations
• Ability to effectively communicate with co-workers and business partners at all levels of the organization (both internal and external).
• Excellent organizational skills with an ability to think proactively and prioritize work.
• Working knowledge of statistical data analysis
• Thorough understanding of validation activities and risk management principles and techniques
• Strong problem-solving and critical thinking skills
• Medical industry or highly regulated industry

• Excellent communication and interpersonal skills must be coupled with public speaking, quick decision making.
• Excellent written and oral communication skills
• Medical component and device manufacturing require strict adherence to standards.
• Strong communication and technical writing skills, interpretation of data, interpersonal skills, ability to work on and lead teams
• Read and interpret data, information, and documents
• Must maintain the ability to work well with others in a variety of situations
• Must be able to multi-task, work under time constraints, problem solve, and prioritize
• Ability to make independent and sound judgments
• Demonstrates enthusiasm, takes accountability, and drives for results.
• Superior organizational and leadership skills with ability to help team grow and thrive
• Able to lead and front multiple third party Medical Device / Pharmaceutical audits.
• Able to interact with global Medical Device / Pharmaceutical agencies in support of queries / product launches.
• Have in-depth / working knowledge of: ISO 13485, US FDA 21 CFR Part 820, ISO14971
• Have strong self-motivation, the ability to work independently, and within a team environment with strong follow up, organization and prioritization skills and excellent attention. Must have a proven track record of developing and maintaining positive customer relationships.
• Able to lead and manage the performance of a multi-functional team.
• Able to organize and prioritise tasks, must be detail orientated and self-motivated.
• Have excellent written and verbal communication skills. Must be able to work in a fast paced environment.
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Able to always comply with the company’s safety and quality policy