{"schemaVersion":"jobsearcher.job.v1","id":"be6b334dfe4aba9703d0d1b7","url":"https://jobsearcher.com/jobs/be6b334dfe4aba9703d0d1b7","canonicalUrl":"https://jobsearcher.com/jobs/be6b334dfe4aba9703d0d1b7","title":"Principal Quality Engineer","description":"We are seeking a highly experienced Principal Quality Engineer to lead quality engineering initiatives in a regulated manufacturing environment. This role provides technical leadership for quality systems, product quality improvements, risk management, CAPA activities, process validation, and compliance programs. The Principal Quality Engineer serves as a subject matter expert, partnering with cross‑functional teams to ensure products meet customer, regulatory, and business requirements while driving continuous improvement and operational excellence.\n\nResponsibilities\n\nProvide technical leadership and mentorship to Quality Engineers and cross‑functional teams.\n\nLead complex investigations involving customer complaints, nonconformances, deviations, and product quality issues.\n\nDrive root cause analysis using methodologies such as 8D, Fishbone, 5 Whys, Fault Tree Analysis, and FMEA.\n\nLead CAPA development, implementation, effectiveness verification, and closure activities.\n\nEnsure compliance with FDA regulations, ISO 13485, ISO 14971, GMP, and other applicable quality standards.\n\nSupport product development activities including Design Controls, Risk Management, Verification & Validation, and Design Transfer.\n\nDevelop and maintain quality plans, inspection strategies, control plans, and quality metrics.\n\nAnalyze quality trends and manufacturing data to identify opportunities for process improvement and risk reduction.\n\nLead internal and external audits, supplier audits, and regulatory inspections.\n\nCollaborate with Manufacturing, R&D, Operations, Regulatory Affairs, and Supply Chain teams to resolve quality issues.\n\nReview and approve validation protocols and reports including IQ, OQ, PQ, TMV, and process validations.\n\nSupport supplier quality management activities including supplier qualification and performance monitoring.\n\nDrive continuous improvement projects utilizing Lean, Six Sigma, and statistical process control methodologies.\n\nReview engineering changes and assess quality and regulatory impacts.\n\nPresent quality performance metrics and recommendations to senior management.\n\nRequirements\n\nBachelor's degree in engineering, Quality, Biomedical Engineering, Mechanical Engineering, Manufacturing Engineering, or related technical field.\n\n8–15+ years of quality engineering experience in Medical Device, Pharmaceutical, Biotechnology, Aerospace, or highly regulated industries.\n\nStrong knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, GMP, and quality management systems.\n\nExtensive experience with CAPA, complaint handling, investigations, risk management, and process validation.\n\nExperience leading audits and interacting with regulatory agencies.\n\nStrong statistical analysis and problem‑solving skills.\n\nProficiency with quality tools including Minitab, SPC, DOE, FMEA, Control Plans, and Risk Assessments.\n\nExcellent technical writing, communication, and leadership skills.\n\nPreferred Qualifications\n\nMaster's degree in engineering or related field.\n\nASQ Certifications such as:\n\nCertified Quality Engineer (CQE)\n\nCertified Six Sigma Black Belt (CSSBB)\n\nCertified Manager of Quality/Organizational Excellence (CMQ/OE)\n\nExperience with medical device product lifecycle management.\n\nExperience supporting global manufacturing operations.\n\nKey Skills\n\nQuality Systems Management\n\nCAPA Leadership\n\nRoot Cause Analysis\n\nDesign Controls\n\nRisk Management (ISO 14971)\n\nProcess Validation\n\nStatistical Analysis\n\nSupplier Quality\n\n#J-18808-Ljbffr","company":"Creative Solutions Services","rawCompany":"creative solutions services","city":"Irvine","state":"CA","isRemote":false,"isActive":false,"createdAt":"2026-06-30T03:24:41.701Z","occupations":[{"code":"11-3051.01","title":"Quality Control Systems Managers","slug":"quality-control-systems-managers"},{"code":"19-4099.01","title":"Quality Control Analysts","slug":"quality-control-analysts"},{"code":"17-2112.02","title":"Validation Engineers","slug":"validation-engineers"}],"industries":[{"code":"325412","title":"Pharmaceutical Preparation Manufacturing","slug":"pharmaceutical-preparation-manufacturing"},{"code":"339113","title":"Surgical Appliance and Supplies Manufacturing","slug":"surgical-appliance-and-supplies-manufacturing"},{"code":"339112","title":"Surgical and Medical Instrument Manufacturing","slug":"surgical-and-medical-instrument-manufacturing"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Principal Quality Engineer","description":"We are seeking a highly experienced Principal Quality Engineer to lead quality engineering initiatives in a regulated manufacturing environment. This role provides technical leadership for quality systems, product quality improvements, risk management, CAPA activities, process validation, and compliance programs. The Principal Quality Engineer serves as a subject matter expert, partnering with cross‑functional teams to ensure products meet customer, regulatory, and business requirements while driving continuous improvement and operational excellence.\n\nResponsibilities\n\nProvide technical leadership and mentorship to Quality Engineers and cross‑functional teams.\n\nLead complex investigations involving customer complaints, nonconformances, deviations, and product quality issues.\n\nDrive root cause analysis using methodologies such as 8D, Fishbone, 5 Whys, Fault Tree Analysis, and FMEA.\n\nLead CAPA development, implementation, effectiveness verification, and closure activities.\n\nEnsure compliance with FDA regulations, ISO 13485, ISO 14971, GMP, and other applicable quality standards.\n\nSupport product development activities including Design Controls, Risk Management, Verification & Validation, and Design Transfer.\n\nDevelop and maintain quality plans, inspection strategies, control plans, and quality metrics.\n\nAnalyze quality trends and manufacturing data to identify opportunities for process improvement and risk reduction.\n\nLead internal and external audits, supplier audits, and regulatory inspections.\n\nCollaborate with Manufacturing, R&D, Operations, Regulatory Affairs, and Supply Chain teams to resolve quality issues.\n\nReview and approve validation protocols and reports including IQ, OQ, PQ, TMV, and process validations.\n\nSupport supplier quality management activities including supplier qualification and performance monitoring.\n\nDrive continuous improvement projects utilizing Lean, Six Sigma, and statistical process control methodologies.\n\nReview engineering changes and assess quality and regulatory impacts.\n\nPresent quality performance metrics and recommendations to senior management.\n\nRequirements\n\nBachelor's degree in engineering, Quality, Biomedical Engineering, Mechanical Engineering, Manufacturing Engineering, or related technical field.\n\n8–15+ years of quality engineering experience in Medical Device, Pharmaceutical, Biotechnology, Aerospace, or highly regulated industries.\n\nStrong knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, GMP, and quality management systems.\n\nExtensive experience with CAPA, complaint handling, investigations, risk management, and process validation.\n\nExperience leading audits and interacting with regulatory agencies.\n\nStrong statistical analysis and problem‑solving skills.\n\nProficiency with quality tools including Minitab, SPC, DOE, FMEA, Control Plans, and Risk Assessments.\n\nExcellent technical writing, communication, and leadership skills.\n\nPreferred Qualifications\n\nMaster's degree in engineering or related field.\n\nASQ Certifications such as:\n\nCertified Quality Engineer (CQE)\n\nCertified Six Sigma Black Belt (CSSBB)\n\nCertified Manager of Quality/Organizational Excellence (CMQ/OE)\n\nExperience with medical device product lifecycle management.\n\nExperience supporting global manufacturing operations.\n\nKey Skills\n\nQuality Systems Management\n\nCAPA Leadership\n\nRoot Cause Analysis\n\nDesign Controls\n\nRisk Management (ISO 14971)\n\nProcess Validation\n\nStatistical Analysis\n\nSupplier Quality\n\n#J-18808-Ljbffr","datePosted":"2026-06-30T03:24:41.701Z","dateModified":"2026-06-30T03:24:41.701Z","hiringOrganization":{"@type":"Organization","name":"Creative Solutions Services","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"Irvine","addressRegion":"CA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"be6b334dfe4aba9703d0d1b7"},"url":"https://jobsearcher.com/jobs/be6b334dfe4aba9703d0d1b7"}}