Quality Engineer

Quality Engineer III And Controlled Substance Program LeadAs 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.As a Quality Engineer III and Controlled Substance Program Lead, you'll help ensure quality excellence and regulatory compliance to DEA across manufacturing operations. You'll help ensure our products meet the highest Quality and regulatory Compliance standards while supporting our mission to enable customers to make the world healthier, cleaner and safer. This role combines technical expertise with quality oversight to maintain robust quality management systems, lead investigations, drive continuous improvement, and ensure GMP/ISO and DEA compliance. The role is responsible for overseeing the Controlled Substance Program to ensure compliance with applicable regulatory requirements and internal quality standards. In addition, the position collaborates cross-functionally with multiple teams to investigate and resolve quality issues, conduct risk assessments, manage CAPA activities, support internal and external audits, and drive continuous quality improvement initiatives. The role requires strong analytical, problem-solving, and communication skills to effectively interface with internal stakeholders, customers, and regulatory agencies while helping establish, maintain, and enhance quality systems and compliance practices.Location: Middletown, VARelocation assistance is NOT provided.Requirements:Education & ExperienceAdvanced degree with 3+ years of experience in Quality Assurance within a regulated industry ORBachelor's degree with 5+ years of experience in Quality Assurance within a regulated industry (pharmaceutical, medical device, biotech, or related field)Preferred Fields of Study: Engineering, Life Sciences, Chemistry or related technical fieldPreferred CertificationsASQ Certifications such as: Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA)Technical & Regulatory ExpertiseStrong knowledge of:cGMP requirementsISO 13485 / ISO 9001 standardsDEA regulationsFDA, EMA, and other applicable regulatory requirementsExperience with quality systems and processes including:CAPA and deviation managementChange controlRisk management and FMEADocument controlInternal and external auditingValidation and qualification protocolsSkills & CompetenciesAdvanced problem-solving and root cause analysis skillsStrong project management capabilitiesExcellent verbal and written communication skillsProficiency with quality management systems/software and Microsoft OfficeKnowledge of statistical analysis and quality toolsAbility to work independently and collaboratively in cross-functional environmentsStrong attention to detail while maintaining a strategic, big-picture perspectiveExcellent interpersonal and stakeholder management skillsAdditional RequirementsAbility to travel up to 25% as neededMust be legally authorized to work in the United States without sponsorship.Must be able to pass a comprehensive background check, which includes a drug screening.