Quality Assurance Manager, Medical Device & Combination Products

1H0 Hospira, Inc.; St. Louis (MO); Híbrido; USD 99 000 - 165 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

401(k) with Pfizer Matching

Health benefits

Paid time off

Relocation assistance

Resumo da oferta

Pfizer is seeking a Manager of Medical Device Quality Assurance within its MDCP Quality Operations. You will lead global quality oversight for MDCP programs, govern design controls, risk management, and regulatory readiness across 50+ markets. The role requires aligning with EU MDR, 21 CFR, and FDA standards to ensure patient safety and product quality.

The position is hybrid with relocation support, offering a base salary with bonus potential and comprehensive Pfizer benefits.

Qualificações

• Minimum 4 years of experience in Quality Assurance, GMP manufacturing, or medical devices.
• Experience with design controls and risk management.

Responsabilidades

• Provide strategic quality oversight for MDCP programs across global markets.
• Lead and govern design controls and risk management activities.
• Resolve complex quality and regulatory issues across cross-functional teams.
• Monitor international regulations and translate into policies and practices.
• Evaluate investigations for completeness and risk relevance.
• Drive process improvements to strengthen quality system maturity.
• Support lifecycle management of marketed products.

Conhecimentos

Quality Assurance

Regulatory Compliance

Design Controls

Risk Management

Cross-functional Collaboration

Quality Systems

Formação académica

Bachelor's degree

Master's degree

PhD

Associate degree

High school diploma

Descrição da oferta de emprego

USE YOUR POWER FOR PURPOSE 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 a strategic pillar within Pfizer's Medical Device and Combination Products (MDCP) Quality Operations global team. Serving as a key global quality partner, you will champion and govern development, sustaining, and post-market activities for MDCP portfolios distributed across 50+ worldwide markets. The Manager of Medical Device Quality Assurance supports the global quality blueprint, ensuring that MDCP delivery systems are developed and sustained in strict compliance with a diverse array of international regulatory standards including ISO 13485, ISO 14971, EU MDR, 21 CFR Part 4, and FDA 21 CFR 820. You will provide strategic and technical quality oversight for design control and risk management for complex programs and guide teams using risk-based decision-making helping 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

• Lead global quality assurance oversight for multiple concurrent global MDCP programs and next-generation delivery platforms, enabling the successful global launch and market sustainability of high-priority assets.


• Serve as a MDCP quality partnerfor global cross-functional teams, providing authoritative, risk-based guidance on design controls, post-approval changes, supplier/component changes, manufacturing transfers, periodic product reviews, post-market surveillance, product remediations, and obsolescence planning.


• Drive the resolution of complex, multi-regional business-critical quality and compliance issues, providing sound recommendations that enable practical, compliant decisions across diverse international markets and fast-paced regulatory environments.


• Actively monitor shifting international regulations (e.g., EU MDR, TGA, ANVISA, NMPA, FDA) 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 in a fast-paced and highly regulated environment.


• 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.

HERE IS WHAT YOU NEED (Minimum Requirements)

Applicant must have a 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, 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.

BONUS POINTS IF YOU HAVE (Preferred Requirements)

• Experience in both medical device and pharmaceutical quality environments, especially combination 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 REQUIREMENT

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

OTHER JOB DETAILS

Relocation support available.

Work Location Assignment: Hybrid - On premise 2-3 days per week.

Last Date to Apply for Job: November 13, 2026.

The role is an independent contributor and does not have any direct reports.

The annual base salary for this position ranges from $99,200.00 to $165,400.00.

In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 12.5% of the base salary and eligibility to participate in our share based long term incentive program.

We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments.

Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage.

Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com).

Pfizer compensation structures and benefit packages are aligned based on the location of hire.

The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

This role is posted in multiple locations.

If you are applying for the role in an secondary job posting location where pay transparency regulations apply, your Talent Advisor will share the local pay information with you during the first interview.

Relocation assistance may be available based on business needs and/or eligibility.

Candidates must be authorized to be employed in the U.S. by any employer.

U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.

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EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.

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Quality Assurance and Control

Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.