Site Quality Lead / Staff Quality Engineer

About the role

The Staff Quality Engineer serves as the Site Quality Lead and a member of the Site Leadership Team, providing strategic quality leadership across the product lifecycle.

Responsibilities

• Adhere to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
• Serve as the site's Management Representative, leading Management Review activities and communicating the health, performance, and effectiveness of the Quality Management System through meaningful quality metrics.
• Provide strategic Quality leadership across the product lifecycle, from product development through commercialization and post-launch support, ensuring quality is designed into products, integrated into business decisions, and continuously improved through customer feedback and operational performance.
• Leverage quality system, product performance, customer feedback, complaint trends, and post-market data to identify emerging risks, drive systemic improvements, and influence product and process decisions across the product lifecycle.
• Prioritize and balance strategic initiatives with operational support, ensuring compliance with applicable regulatory and corporate quality requirements.
• Partner with cross-functional teams to establish robust quality requirements, qualification strategies, supplier capabilities, inspection methods, and process controls that drive defect prevention and improve product quality throughout the product lifecycle.
• Represent the site during internal, customer, and regulatory inspections, ensuring timely and effective responses to audit observations.
• Influence cross-functional teams, coach quality best practices, and foster accountability across the organization.
• Contribute as a member of the Site Leadership Team by influencing site strategy, operational excellence, resource prioritization, and business decisions through the lens of Quality.

Requirements

• Bachelor's degree in Engineering, Life Sciences, or related scientific discipline.
• 8+ years of Quality experience in the medical device, IVD, biotechnology, or pharmaceutical industry.
• Demonstrated experience supporting Design Controls and product development.
• Demonstrated experience implementing and maintaining Quality Management Systems within a regulated medical device, IVD, or biotechnology environment, including knowledge of ISO 13485, FDA QMSR, Design Controls, and Risk Management.

Qualifications

• Demonstrated ability to influence cross-functional teams and lead initiatives without direct authority.
• Experience leading Quality System processes, including CAPA, audits, change control, and regulatory inspections.
• Strong analytical, communication, and problem-solving skills.

Skills

• Demonstrated ability to influence cross-functional teams and lead initiatives without direct authority.
• Experience leading Quality System processes, including CAPA, audits, change control, and regulatory inspections.
• Strong analytical, communication, and problem-solving skills.

Benefits

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
• Retail and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards