Quality Assurance Manager, Medical Device & Combination Products

Why Patients Need You

Everything we do every day is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible innovative and customer oriented. Whether you are involved in development maintenance compliance or analysis through research programs your contribution will directly impact patients.

What You Will Achieve

This role is part of Pfizers Medical Device and Combination Products (MDCP) Quality Operations this role you will serve as a key quality partner supporting development sustaining and complaint activities across the product lifecycle. The Manager Medical Device Quality Assurance is responsible for ensuring that medical devices and combination products are developed and maintained in compliance with applicable design control requirements and key regulatory standards including 21 CFR 820 ISO 13485 and ISO 14971. You will provide strategic and technical quality oversight for both complex programs and for complaint investigations guide risk-based decision-making and help ensure compliance with applicable design control and quality system requirements. You will work across functions to resolve issues strengthen processes and support product quality patient safety and regulatory readiness.

How You Will Achieve It

• Provide quality oversight for MDCP programs across both development and sustaining lifecycle activities.

• Serve as a key quality partner for cross-functional teams providing risk-based guidance on design controls risk management quality systems vendor management change control and complaint-related activities.

• Support on-market and sustaining activities including post-approval changes supplier and component changes manufacturing transfers periodic product reviews post-market surveillance and product remediation or obsolescence planning.

• Assess the quality safety and regulatory impact of product and process changes to help ensure continued compliance and maintenance of design and risk management documentation.
• Review and approve device complaint investigations with a focus on technical rigor documentation quality and timely closure
• Evaluate investigation content for completeness scientific rationale issue linkage risk alignment and potential CAPA relevance
• Partner with teams to resolve complex quality issues provide sound recommendations and enable practical compliant decisions in a fast-paced and highly regulated environment.

• Monitor changes in global regulations and help translate evolving requirements into effective policies procedures and quality system practices.

• Identify and drive opportunities to strengthen processes improve consistency and advance quality system maturity across the MDCP development and sustaining space.

• Promote alignment in the interpretation and application of quality policies and procedures across teams and activities.

• Apply technical expertise across later-phase product lifecycle activities including verification validation process validation stability-related considerations and sustaining lifecycle management of marketed products.

Qualifications

Must-Have

• Applicant must have a bachelors degree with at least 4 years of experience; OR a masters degree with at least 2 years of experience; OR a PhD with 0 years of experience; OR an associates degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience working in Quality Assurance GMP manufacturing environment pharmaceutical environment or medical device space

• Experience supporting quality activities in medical devices combination products pharmaceuticals or another highly regulated industry.

• Working knowledge of applicable quality and regulatory requirements such as design controls risk management and quality system requirements relevant to medical devices and/or combination products or pharmaceutical products.

• Experience supporting product development and/or sustaining lifecycle activities including change control and ongoing product maintenance.

• Ability to work effectively across cross-functional teams and make sound risk-based decisions in complex or ambiguous situations.

• Strong communication influencing and collaboration skills.

• Strong analytical skills and ability to work effectively with quality documentation systems and data.

Nice-to-Have

• Experience in both medical device and pharmaceutical quality environments especiallycombination products.

• Strong experience with design controls and risk management across the product lifecycle from development through launch and post-market sustaining.

• Experience supporting on-market product changes post-approval changes supplier or component changes and manufacturing transfers.

• Experience with post-market surveillance complaint evaluation periodic product review and remediation activities.

• Working knowledge of combination product regulations including 21 CFR Part 4 and broader medical device regulatory expectations.

• Experience partnering with suppliers vendors or external manufacturers in a regulated environment.

• Experience applying a risk-based approach to complex quality decisions in fast-paced cross-functional settings.

• Familiarity with verification validation process validation usability software or other technical development areas relevant to medical device programs.

Non-Standard Work Schedule Travel or Environment Requirements

• The role may include frequent business travel across Pfizer manufacturing sites vendors and suppliers.

Work Location Assignment:Hybrid

Purpose

Breakthroughs that change patients lives... At Pfizer we are apatient centric company guided by our four values: courage joy equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.

Digital Transformation Strategy

One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.

Flexibility

We aim to create a trusting flexible workplace culture which encourages employees to achieve work life harmony attracts talent and enables everyone to be their best working start the conversation!

Equal Employment Opportunity

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer Pfizer iscommitted to celebratingthisin all itsforms allowing for us to be as diverse as the patients and communities we serve. Together we continue to build a culture that encourages supports and empowers our employees.

DisAbility Confident

We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people especially those with unique superpowers. Your journey with Pfizer starts here!

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