Quality Engineer/Controlled Substance Program Lead

Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description 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 and enable our customers to make the world healthier, cleaner and safer. Discover Impactful Work Join the Clinical Diagnostics Division as a Quality Engineer III / Controlled Substance Program Lead . This role combines quality engineering expertise with leadership of the site’s Controlled Substance Program to support regulatory compliance, product quality, and continuous improvement across manufacturing operations. You will partner with Quality, Manufacturing, Operations, Regulatory Affairs, and other teams to maintain effective quality systems, investigate and resolve quality issues, manage CAPAs and risk assessments, support audits and inspections, and strengthen compliance practices. This position is based in Middletown, VA . Relocation assistance is not provided.

Lead and support the site Controlled Substance Program in accordance with applicable DEA requirements and internal quality standards. Serve as a site resource for controlled-substance compliance and support readiness for DEA inspections and other applicable audits. Apply quality engineering principles to identify risks, investigate quality issues, perform root cause analysis, and implement sustainable corrective and preventive actions (CAPAs). Lead or support deviations, nonconformances, change controls, risk assessments, and FMEA activities. Support validation and qualification activities and associated quality documentation. Participate in internal, customer, third-party, and regulatory audits and inspections, including responses to observations and findings. Analyze quality and compliance data to identify trends, risks, and continuous improvement opportunities. Partner cross-functionally to strengthen quality systems, regulatory compliance, and manufacturing processes.

Advanced degree in Engineering, Life Sciences, Chemistry, or a related technical field with 3+ years of relevant quality or compliance experience in a regulated industry; or Bachelor’s degree in a related technical field with 5+ years of relevant quality or compliance experience in a regulated industry. Experience in pharmaceutical, medical device, biotechnology, diagnostics, or another regulated life sciences environment preferred. Experience supporting controlled-substance programs and/or DEA-regulated activities strongly preferred. Knowledge, Skills and Abilities Strong knowledge of cGMP and applicable quality and regulatory requirements. Knowledge of DEA regulations, ISO 13485/ISO 9001, FDA requirements, and related regulatory standards. Experience with CAPA, investigations, change control, risk management, auditing, and validation/qualification. Strong root cause analysis, problem-solving, project-management, and organizational skills. Knowledge of statistical analysis and quality tools. Strong written and verbal communication skills with the ability to collaborate effectively across functions. Proficiency with quality management systems/software and Microsoft Office. Preferred Certifications ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or other relevant quality/compliance certification. Additional Requirements Ability to travel up to 25%, as needed. Must meet applicable requirements for employment in the United States. Must be able to satisfy applicable pre-employment screening requirements for the position.

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