Sr. Quality Manager

Job Summary

In this role you will proactively develop, lead, and drive the execution of the quality assurance strategy across the West, Tempe, AZ 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 West, Grand Rapids and interacts with the team to ensure business objectives are aligned and that the company is performing to operational objectives.

Reports directly to the Director, Quality Operations.

Essential Duties and Responsibilities :

Although much of the work performed in this role impacts the local team, this role also includes the opportunity to provide input into enterprise quality system initiatives which includes but is not limited to the quality system initiatives which possess global impact.

• Reporting to the Director, Quality Operations, the role will play a critical part in the company’s business planning / strategy development.
• Lead the Quality function for medical device products and components moulded, 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 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.

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 West 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 West 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 West, Grand Rapids QA in line with Sister Site agreement requirements for products manufactured at Grand Rapids on behalf of other West 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 West, 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 West, 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 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
• Identification and development of talent to include performance management and succession planning (in the West Talent Gateway).
• Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
• Compliance to all site Environmental, Health and Safety requirements, training, and regulations.
• Compliance to all local site company policies, procedures, and corporate policies.
• Perform additional duties at the request of the direct supervisor.

Basic Qualifications :

• Must be Degree qualified in a relevant discipline or equivalent experience
• Must have at least 10 years Quality / Regulatory management experience in a high-volume Medical Device / Pharmaceutical environment.
• Ideally be minimum Greenbelt’ Lean Sigma trained with a proven track record of leading multiple value-add programs.

Preferred Knowledge, Skills and Abilities :

• 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
• Direct / Indirect Reports : Approximately 65 employees

Travel Requirements :

Travel to other West sites as necessary / conduct external audits (

Physical & Mental Requirements :

• Work in a manufacturing environment, subject to heat and cold as well as loud noise.
• Work in an office environment. At times must sit for extended periods of time.
• Ability to effectively communicate and comprehend complex ideas and concepts.
• Use written and oral communication skills.
• 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.
• Observe and interpret situations, analyze and solve problems.

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