Thermo Fisher Scientific is seeking a Quality Engineer III to join the Marietta, Ohio site. You will serve as a subject matter expert for quality systems and manufacturing quality support, lead investigations into quality events using structured root cause analysis, and drive corrective and preventive actions (CAPAs) through implementation and effectiveness verification. You will conduct risk assessments and support FMEA activities to proactively reduce risk, assist with internal, customer, and regulatory audits, and help maintain inspection readiness. Collaborate with Manufacturing, Engineering, Operations, and Regulatory teams to resolve quality issues and implement sustainable improvements, ensuring compliance with FDA regulations, GMP requirements, and ISO quality standards. Additional responsibilities include developing, reviewing, and improving quality documentation, procedures, and processes; monitoring quality performance metrics; and championing a culture of quality, accountability, and continuous improvement. Qualifications include a Bachelor's degree in Mechanical or Industrial Engineering or a related technical field, at least 2 years of quality engineering or quality assurance experience in a regulated environment (medical device, pharmaceutical, biotechnology, or similar manufacturing), and experience with Quality Management Systems (CAPA, deviation management, change control, risk management, audits, document control). Preferred qualifications include ASQ CQE or CQA certifications, experience in FDA-regulated and ISO-certified environments, and knowledge of I
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Thermo Fisher Scientific is seeking a Quality Engineer III to join the Marietta, Ohio site. You will serve as a subject matter expert for quality systems and manufacturing quality support, lead investigations into quality events using structured root cause analysis, and drive corrective and preventive actions (CAPAs) through implementation and effectiveness verification. You will conduct risk assessments and support FMEA activities to proactively reduce risk, assist with internal, customer, and regulatory audits, and help maintain inspection readiness. Collaborate with Manufacturing, Engineering, Operations, and Regulatory teams to resolve quality issues and implement sustainable improvements, ensuring compliance with FDA regulations, GMP requirements, and ISO quality standards. Additional responsibilities include developing, reviewing, and improving quality documentation, procedures, and processes; monitoring quality performance metrics; and championing a culture of quality, accountability, and continuous improvement. Qualifications include a Bachelor's degree in Mechanical or Industrial Engineering or a related technical field, at least 2 years of quality engineering or quality assurance experience in a regulated environment (medical device, pharmaceutical, biotechnology, or similar manufacturing), and experience with Quality Management Systems (CAPA, deviation management, change control, risk management, audits, document control). Preferred qualifications include ASQ CQE or CQA certifications, experience in FDA-regulated and ISO-certified environments, and knowledge of I
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3 active roles from this employer in the JobMatcher catalog.
3 active roles from this employer in the JobMatcher catalog.