At a Glance
- Tasks: Ensure quality and compliance for medical devices and combination products throughout their lifecycle.
- Company: Join Pfizer, a leader in healthcare innovation dedicated to improving patient lives.
- Benefits: Enjoy competitive pay, flexible work options, and comprehensive health benefits.
- Other info: Hybrid work model with opportunities for travel and professional growth.
- Why this job: Make a real difference in patient safety and product quality in a dynamic environment.
- Qualifications: Bachelor's degree with relevant experience in quality assurance or medical devices.
The predicted salary is between 56700 - 69300 £ per year.
Quality Assurance Manager, Medical Device & Combination Products
We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.
To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.
Pfizer Global Supply proudly shoulders the responsibility of manufacturing and distributing our wide-ranging pharmaceutical products.
Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.
Transforming Delivery of high quality products
Pfizer, We are one
PGS - Manufacture the Future
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 Pfizer’s Medical Device and Combination Products (MDCP) Quality Operations team. In 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 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.
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
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Quality Assurance Manager, Medical Device & Combination Products employer: Pfizer, S.A. de C.V
Pfizer is an exceptional employer that prioritises employee well-being and professional growth, offering a hybrid work model that fosters flexibility while ensuring collaboration. With competitive compensation packages, including performance bonuses and comprehensive health benefits, employees are supported in both their personal and professional lives. The vibrant work culture encourages innovation and engagement, making it an ideal place for those looking to make a meaningful impact in the healthcare sector.
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We think this is how you could land Quality Assurance Manager, Medical Device & Combination Products
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We think you need these skills to ace Quality Assurance Manager, Medical Device & Combination Products
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Pfizer, S.A. de C.V!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Pfizer, S.A. de C.V that you're not just a fit for the job but also a safety-conscious candidate!
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Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Pfizer, S.A. de C.V, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Pfizer, S.A. de C.V
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Pfizer, S.A. de C.V that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
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If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
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Take some time to familiarise yourself with Pfizer, S.A. de C.V’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
