Senior Quality Engineer

Responsibilities

• Lead remediation of metrology and calibration programs in regulated industries
• Conduct gap assessments and develop sustainable remediation plans
• Address audit observations, CAPAs, and regulatory findings
• Apply knowledge of dimensional metrology, measurement system analysis, and calibration principles
• Perform fitness-for-use evaluations and apply decision rules
• Support calibration and troubleshooting of equipment including ultrasonic welders, vision systems, and CMMs
• Evaluate out-of-tolerance (OOT) conditions and determine product impact
• Author and revise calibration procedures, deviations, and risk assessments
• Support internal, customer, and regulatory audits
• Use statistical tools like Minitab to evaluate measurement trends

Requirements

• Bachelor’s degree in Engineering, Quality, Metrology, or a related technical discipline
• 5+ years of experience in metrology or calibration systems within a regulated industry
• Demonstrated experience leading calibration program remediation and CAPA execution
• Strong technical expertise in dimensional metrology and MSA
• Advanced understanding of measurement uncertainty, tolerance analysis, and traceability
• Hands-on experience with manufacturing and inspection equipment
• Strong knowledge of ISO 13485, 21 CFR Part 820, and ISO 17025
• Proficiency with Minitab or equivalent statistical tools
• Strong project management and analytical skills

Preferred Qualifications

• Experience working in medical device metrology programs
• Familiarity with cleanroom environments and standards (ISO 9001, ISO 10012)
• Working knowledge of ProCal V5 and Siemens Teamcenter

About the Company

BioPharma Consulting JAD Group provides specialized consulting services within regulated manufacturing environments.