Description
At Pfizer, you will contribute to the development, maintenance, and compliance of medical devices and combination products. As a Manager of Medical Device Quality Assurance, you will oversee global quality assurance for multiple medical device programs, providing technical expertise and risk-based guidance to cross-functional teams.
Key Responsibilities:
- Lead global quality assurance oversight for multiple concurrent global MDCP programs and next-generation delivery platforms.
- Serve as a MDCP quality partner for global cross-functional teams, providing authoritative, risk-based guidance on design controls, post-approval changes, and supplier/component changes.
- Drive the resolution of complex, multi-regional business-critical quality and compliance issues.
- Monitor shifting international regulations and translate evolving requirements into unified global policies, procedures, and quality system practices.
- 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.
- Identify and drive opportunities to strengthen processes, improve consistency, and advance quality system maturity.
Requirements:
- Bachelor's degree with at least 4 years of experience; OR a master's degree with at least 2 years of experience; OR a PhD with 0+ years of experience; OR an associate's degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience.
- 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.
- 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.
Preferred Qualifications:
- Experience in both medical device and pharmaceutical quality environments, especially combination products.
- Strong experience with design controls and risk management across the product lifecycle.
- 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.
What We Offer:
- Annual base salary ranging from $99,200.00 to $165,400.00.
- Eligibility to participate in Pfizer’s Global Performance Plan with a bonus target of 12.5% of the base salary.
- Eligibility to participate in our share-based long-term incentive program.
- Comprehensive benefits package, including 401(k) plan with Pfizer Matching Contributions, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits.