Bolt Medical
Position Overview:
We are seeking an experienced and strategic Quality Engineer to lead our CAPA program and drive continuous improvement across the organization. This role is critical in driving continuous improvement by leading root cause investigations, implementing corrective and preventive actions, and ensuring compliance with regulatory and quality standards
Responsibilities:
Serve as the CAPA program owner, overseeing all aspects of the CAPA lifecycle from initiation through closure. Lead/Support complex root cause investigations using structured problem-solving tools (e.g., 5 Whys, Fishbone, 8D, FMEA). Conduct thorough root cause analyses (RCA) using tools such as 5 Whys, Fishbone diagrams, and FMEA. Facilitate cross-functional investigations to identify root causes using tools such as 5 Whys, Fishbone diagrams, and 8D. Collaborate cross-functionally with Engineering, Manufacturing, Regulatory, and Operations to develop and implement robust corrective and preventive actions. Monitor effectiveness of CAPAs and track metrics to identify trends and areas for improvement. Maintain CAPA documentation in compliance with ISO 13485, FDA 21 CFR Part 820, or other applicable standards. Support internal and external audits by providing CAPA records and participating in audit activities. Assist in training personnel on CAPA procedures and quality system requirements. Contribute to continuous improvement initiatives and quality system enhancements. Other duties as assign
Qualification: Bachelors degree in engineering, Life Sciences, or related field. 5+ years of experience in Quality Engineering, preferably in a regulated industry (e.g., medical devices or pharma). Proven experience managing CAPA processes and conducting root cause investigations. Proficiency with quality tools and methodologies (e.g., Six Sigma, Lean, Kaizen). Strong understanding of regulatory requirements including
FDA QSR, ISO 13485, EU MDR,
and risk management per ISO 14971. Experience with electronic Quality Management Systems (eQMS) such as TrackWise, or similar. Excellent communication, documentation, and project management skills. Certified Quality Engineer (CQE), Six Sigma Green/Black Belt, or similar certification. Experience with complaint handling, nonconformance investigations, and post-market surveillance
Serve as the CAPA program owner, overseeing all aspects of the CAPA lifecycle from initiation through closure. Lead/Support complex root cause investigations using structured problem-solving tools (e.g., 5 Whys, Fishbone, 8D, FMEA). Conduct thorough root cause analyses (RCA) using tools such as 5 Whys, Fishbone diagrams, and FMEA. Facilitate cross-functional investigations to identify root causes using tools such as 5 Whys, Fishbone diagrams, and 8D. Collaborate cross-functionally with Engineering, Manufacturing, Regulatory, and Operations to develop and implement robust corrective and preventive actions. Monitor effectiveness of CAPAs and track metrics to identify trends and areas for improvement. Maintain CAPA documentation in compliance with ISO 13485, FDA 21 CFR Part 820, or other applicable standards. Support internal and external audits by providing CAPA records and participating in audit activities. Assist in training personnel on CAPA procedures and quality system requirements. Contribute to continuous improvement initiatives and quality system enhancements. Other duties as assign
Qualification: Bachelors degree in engineering, Life Sciences, or related field. 5+ years of experience in Quality Engineering, preferably in a regulated industry (e.g., medical devices or pharma). Proven experience managing CAPA processes and conducting root cause investigations. Proficiency with quality tools and methodologies (e.g., Six Sigma, Lean, Kaizen). Strong understanding of regulatory requirements including
FDA QSR, ISO 13485, EU MDR,
and risk management per ISO 14971. Experience with electronic Quality Management Systems (eQMS) such as TrackWise, or similar. Excellent communication, documentation, and project management skills. Certified Quality Engineer (CQE), Six Sigma Green/Black Belt, or similar certification. Experience with complaint handling, nonconformance investigations, and post-market surveillance