Senior Quality Manager

One of our large Medical Device Packaging clients is hiring for a Senior Quality Manager to join their team. In this role you will proactively develop, lead, and drive the execution of the quality assurance strategy across the Grand Rapids site by overseeing the elements of quality operations, quality control and quality system functions. The position is a key and active member of the Site Leadership Team in Grand Rapids and interacts with the team to ensure business objectives are aligned and that the company is performing to operational objectives. This role will report directly into the Director, Quality Operations.



Responsibilities include:

- Lead the Quality function for medical device products and components molded, assembled, and packed by West, Grand Rapids.

- The role will also have a dotted line reporting relationship to the Director, Operations, Grand Rapids to ensure development and alignment of the site business plan including support to the other senior managers in the execution of same.

- Establishing the sites quality strategy in conjunction with the other members of the Site's Leadership Team and the Director, Quality Operations.

- Cultivate a positive working relationship with the 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 product quality and reliability meets or exceeds customers' expectations.

- QA representative participating in customer face to face steering committees and business review which originate from site customer base. Chairing customer meetings with respect to Quality standards and expectations.

- Directs the Grand Rapids Quality functions, such as Operations QA, Validation QA, Supplier QA, QA Programs, Systems, Microbiology and Metrology, to ensure all product are developed, manufactured, tested, stored, and distributed in accordance with regulatory, customer and standards, guidelines and procedures

- 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

- Directs Grand Rapids QA in line with Sister Site agreement requirements for products manufactured at Grand Rapids on behalf of other sites

- 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 developing a culture of risk activities in the development and maintenance of product/ process risk and hazard analysis in accordance with ISO 14971.

- Establish, monitor, and report on appropriate Key performance indicators which underpin the performance of Grand Rapids relative to Quality for Operations, Quality System, Product Development and New Product Introductions

- 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.

- 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

- Ensures Grand Rapids has an internal audit program, supplier audit program and all audits are conducted to drive improvements and achieve site KPIs

- Play a role as a key contributor to Global Enterprise Quality documentation updating, including where appropriate, leading any updates.

- Participate in and drive compliance to global harmonization initiatives

- Responsible for the quality data trending e.g., CAPA, Deviations, Customer Complaints and Change Requests and driving quality improvements across the site

- As the management representative, ensures the quality system is implemented and its integrity maintained. Also. leads and ensures facility readiness for all third part audits including notified bodies.

- Ensures all Quality and Regulatory correspondence (internal and external) is aligned and compliant with the clients 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

-Identification and development of talent to include performance management and succession planning

- Compliance to all site Environmental, Health and Safety requirements, training, and regulations.



This role will have 5 direct reports and they are looking for someone that has an operations background, then moved into Quality

10+ years in Quality/ Regulatory management experience, preferably in a Medical Device or Pharmaceutical environment

Greenbelt Lean Sigma

Extensive Audit Experience

Continuous Improvement

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

Master control or SAP experience

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.