Quality Assurance and Control Engineer

This role has primary responsibility for confirmation that medical devices and drug/device combination products meet their intended function.

In this role, you will:

• Partner with Systems engineers in defining product requirements such that they are verifiable
• Develop test fixtures, test methods, and perform Test Method Validation activities
• Coordinate with internal and external partners and suppliers to procure test samples and manage conditioning and accelerated aging studies
• Ensure integrity and compliance of data according to Standard Operating Procedures
• Develop Verification Plans including test strategy
• Utilize technical writing and statistical data analysis skills to write protocols and reports
• Conduct root cause analysis and derive recommendations based on analysis of data
• Translate inspections and tests methods into component and product specifications
• Potential for Project Team lead responsibilities including MS Project schedule creation/maintenance, device team meetings, and overall team management.

Requirements:

• Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with 0+ years of experience; OR an associate's degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant experience

Preferred Requirements:

• Experience in the pharmaceutical or biotechnology industry
• Familiarity with Good Manufacturing Practices (GMP)
• Experience with statistical software (e.g., Minitab, JMP)
• Ability to lead cross-functional teams
• Strong organizational skills
• Adaptability and flexibility in a dynamic work environment
• Ability to mentor and develop junior team members
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity.

Benefits:

• Comprehensive and generous benefits and programs to help colleagues lead healthy lives and support each of life's moments
• 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
• Health benefits to include medical, prescription drug, dental and vision coverage