Overview This job is with Thermo Fisher Scientific, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. Work Schedule First Shift (Days) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards Responsibilities As a Quality Engineer III, help ensure quality excellence and regulatory compliance across manufacturing operations. Ensure products meet the highest standards while supporting the mission to enable customers to make the world healthier, cleaner and safer. Combine technical expertise with quality oversight to maintain robust quality management systems, lead investigations, drive continuous improvement, and ensure GMP/ISO compliance. Work with multiple teams to resolve quality issues, conduct risk assessments, manage CAPAs, support audits, and implement quality initiatives. Interface with internal teams and external customers/regulators, requiring strong analytical and communication skills. Help establish and maintain quality standards while supporting a culture of continuous improvement and compliance. May require travel up to 25%. Qualifications Advanced Degree plus 3 years of experience, or Bachelor's Degree plus 5 years of experience in quality assurance in regulated industry (pharmaceutical, medical device, or biotech) Preferred Fields of Study: Engineering, Life Sciences, Chemistry or related technical field ASQ certifications (CQE, CQA) desired Strong knowledge of cGMP, ISO 13485/9001, and applicable regulatory requirements (FDA, EMA, etc.) Expertise in quality systems including CAPA and deviation management, change control, risk management and FMEA, document control, internal/external auditing Advanced problem-solving and root cause analysis skills Excellent project management abilities Strong verbal and written communication skills Proficiency with quality management software and MS Office Experience with validation and qualification protocols Knowledge of statistical analysis and quality tools Ability to work both independently and collaboratively Strong attention to detail while maintaining broad perspective Excellent interpersonal skills for cross-functional collaboration Additional language skills may be beneficial #J-18808-Ljbffr
Job Title
Quality Engineer B