R-01364732

Guilford, CT (site based) As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer. Clinical Next Generation Sequencing Division (CSD) provides sample-to-answer instruments, software, and reagent solutions. CSD is the market leader in targeted sequencing and clinical next-generation sequencing and holds a leading position in research markets. 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. This role enables compliant innovation, drives continuous improvement, and ensures an effective Quality Management System supporting the site's responsibilities as an FDA-registered Specification Developer. This role combines strategic leadership with hands-on ownership of the site's Quality Management System and core quality processes, requiring the ability to effectively balance long-term quality strategy with day-to-day operational execution. The role collaborates closely with Global Design Quality, Research & Development, Supplier Quality, and Operations to drive product quality improvements across the product lifecycle, achieve site quality objectives, and ensure quality is integrated into product and process decisions while maintaining an inspection-ready state and enabling compliant innovation. Own the effectiveness of the site's Quality Management System, establishing priorities, balancing strategic initiatives with operational support, and ensuring compliance with applicable regulatory and corporate quality requirements. 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. Partner with Global Design Quality, Manufacturing, Supplier Quality, Regulatory Affairs, and cross-functional teams to ensure the site fulfills its responsibilities as an FDA-registered Specification Developer and to drive alignment across product requirements, supplier performance, and manufacturing readiness. Own the execution and continuous improvement of site Quality System processes, including CAPA, deviations, change control, document control, training, internal audits, and Management Review, ensuring ongoing compliance and inspection readiness. Drive strategic quality improvements by identifying systemic risks, simplifying quality processes, and using quality metrics to influence business decisions and continuous improvement initiatives. 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. Provide independent quality guidance and risk-based decision making to support compliant product development while enabling innovation and business objectives. Represent the site during internal, customer, and regulatory inspections, ensuring timely and effective responses to audit observations. Promote a proactive quality culture by influencing cross-functional teams, coaching quality best practices, and fostering 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.

Education:

Bachelor's degree in Engineering, Life Sciences, or related scientific discipline.

Experience:

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.

Knowledge, Skills, Abilities:

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. Preferred Qualifications 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. Compensation and Benefits The salary range estimated for this position based in Connecticut is $103,100.00-$150,000.00. 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. 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