Site Quality Lead / Staff Quality Engineer
About The Position
The Staff Quality Engineer serves as the Site Quality Lead and a member of the Site Leadership Team at Thermo Fisher Scientific’s Clinical Next Generation Sequencing Division. This site-based role provides strategic quality leadership across the product lifecycle and hands-on ownership of the site’s Quality Management System (QMS). The position supports the site’s responsibilities as an FDA-registered Specification Developer, enabling compliant innovation while maintaining regulatory compliance and inspection readiness. The role collaborates with Global Design Quality, Research & Development, Supplier Quality, Operations, Manufacturing, Regulatory Affairs, and other cross-functional teams to integrate quality into product and process decisions. It balances long-term quality strategy with day-to-day operational execution, using quality metrics, product performance, customer feedback, complaint trends, and post-market data to identify risks and drive improvements. The position is based at the Guilford, Connecticut site and works first shift in laboratory and office environments. Adherence to GMP safety standards is required, and some PPE is required.
Requirements
- Bachelor’s degree in Engineering, Life Sciences, or a related scientific discipline.
- At least 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 in a regulated medical device, IVD, or biotechnology environment.
- Knowledge of ISO 13485, FDA QMSR, Design Controls, and Risk Management.
- 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.
Nice To Haves
- Experience supporting complex instrument development and commercialization.
- Experience working with contract manufacturers, supplier quality organizations, or complex supply chains.
- Knowledge of APQP, PPAP, FMEA, MSA, SPC, or other advanced quality methodologies.
- ASQ Certified Quality Engineer (CQE) or equivalent certification.
Responsibilities
- Own the effectiveness of the site’s Quality Management System, setting priorities and ensuring compliance with applicable regulatory and corporate quality requirements.
- Serve as the site’s Management Representative, lead Management Review activities, and communicate QMS health and performance through meaningful quality metrics.
- Provide quality leadership across product development, commercialization, and post-launch support, ensuring quality is designed into products and continuously improved.
- Use QMS, product performance, customer feedback, complaint trends, and post-market data to identify emerging risks and drive systemic improvements.
- Partner with cross-functional teams to fulfill the site’s responsibilities as an FDA-registered Specification Developer and align product requirements, supplier performance, and manufacturing readiness.
- Own and continuously improve site quality processes, including CAPA, deviations, change control, document control, training, internal audits, and Management Review.
- Identify systemic risks, simplify quality processes, and use quality metrics to influence business decisions and continuous improvement initiatives.
- Help establish quality requirements, qualification strategies, supplier capabilities, inspection methods, and process controls to prevent defects and improve product quality.
- Provide independent quality guidance and risk-based decision-making to support compliant product development and business objectives.
- Represent the site during internal, customer, and regulatory inspections and ensure timely, effective responses to audit observations.
- Promote a proactive quality culture by influencing cross-functional teams, coaching quality best practices, and fostering accountability.
- Contribute to site strategy, operational excellence, resource prioritization, and business decisions as a member of the Site Leadership Team.
Benefits
- 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 of paid time off and 10 paid holidays annually.
- Paid parental leave, including 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.
- Competitive 401(k) U.S. retirement savings plan.
- Employees’ Stock Purchase Plan offering eligible colleagues the opportunity to purchase company stock at a discount.
- Variable annual bonus eligibility based on company, team, and/or individual performance results in accordance with company policy.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
