Senior Quality Assurance Engineer
3 weeks ago
Senior Quality Assurance Engineer (Medical Devices) Direct message the job poster from Quaero Life Science Senior Quality Assurance Engineer (Medical Devices) Join a growing and innovative medical device manufacturing organization committed to improving patient outcomes through quality and compliance. We are seeking a highly experienced and motivated Senior Quality Assurance Engineer to lead quality systems and product quality initiatives, helping drive ISO 13485 certification and ensure world?class regulatory compliance. Position Summary The Senior Quality Assurance Engineer will be responsible for leading and supporting quality system initiatives, product quality activities, and regulatory compliance across the organization. The ideal candidate will have a minimum of 10 years of experience in the medical device industry, a strong background in ISO 13485 and FDA 21 CFR Part 820, and demonstrated success in helping organizations achieve and maintain ISO 13485 certification. Key Responsibilities Lead, implement, and maintain a robust Quality Management System (QMS) compliant with ISO 13485, FDA 21 CFR Part 820, and other global standards. Act as the Quality lead for ISO 13485 certification or recertification, including gap assessments, audit readiness, and CAPA management. Drive continuous improvement across document control, training, CAPA, internal audits, supplier quality, and risk management. Coordinate and support internal, supplier, and external (Notified Body/FDA) audits. Ensure product realization processes meet regulatory and quality requirements throughout the lifecycle. Support design control activities, risk management (ISO 14971), and process validation (IQ/OQ/PQ). Lead nonconformance investigations, root cause analysis, and CAPA execution for product and process issues. Collaborate cross?functionally to ensure robust product and process quality, including supplier quality and complaint handling. Provide training and mentorship to teams on quality and compliance principles. Promote a proactive quality culture aligned with regulatory and customer expectations. Required Qualifications Bachelor degree in Engineering, Life Sciences, or related technical field (Masters preferred). Minimum of 10 years of experience in Quality Assurance within the medical device industry. Proven experience developing, implementing, and maintaining QMS compliant with ISO 13485 and FDA 21 CFR Part 820. Demonstrated success leading ISO 13485 certification or recertification efforts. Strong understanding of risk management (ISO 14971), design control, and process validation principles. Experience with CAPA, root cause analysis, nonconformance management, and complaint handling. Excellent communication, analytical, and cross?functional collaboration skills. Preferred Qualifications Certified Lead Auditor (ISO 13485) or ASQ Certified Quality Engineer (CQE). Experience with EU MDR and/or MDSAP compliance frameworks. Familiarity with electromechanical or sterile medical devices. Experience supporting new product introduction (NPI) or technology transfer. Quality Leadership and Influence. Regulatory and Compliance Acumen. Analytical and Problem?Solving Skills. Project Management and Continuous Improvement. Effective Communication and Team Collaboration. This role may be on?site in Wilmington, MA. Limited travel (
-
Quality Assurance Associate
2 weeks ago
Wilmington, United States Quality Chemical Laboratories Full timeQuality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing laboratory in Wilmington, is seeking a qualified candidate for the position of Manufacturing Quality Assurance Associate. This position, in the Manufacturing Quality Assurance department, requires a Bachelor’s degree or higher in a scientific or engineering discipline...
-
Quality Assurance Associate
3 weeks ago
Wilmington, United States Quality Chemical Laboratories Full timeQuality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing laboratory in Wilmington, is seeking a qualified candidate for the position of Manufacturing Quality Assurance Associate. This position, in the Manufacturing Quality Assurance department, requires a Bachelor’s degree or higher in a scientific or engineering discipline...
-
Quality Assurance Associate
2 weeks ago
Wilmington, NC, United States Quality Chemical Laboratories Full timeQuality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing laboratory in Wilmington, is seeking a qualified candidate for the position of Manufacturing Quality Assurance Associate. This position, in the Manufacturing Quality Assurance department, requires a Bachelor’s degree or higher in a scientific or engineering discipline...
-
Quality Assurance Associate
1 week ago
Wilmington, NC, United States Quality Chemical Laboratories Full timeQuality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing laboratory in Wilmington, is seeking a qualified candidate for the position of Manufacturing Quality Assurance Associate. This position, in the Manufacturing Quality Assurance department, requires a Bachelor’s degree or higher in a scientific or engineering discipline...
-
Quality Assurance Associate
5 days ago
Wilmington, NC, United States Quality Chemical Laboratories Full timeQuality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing laboratory in Wilmington, is seeking a qualified candidate for the position of Manufacturing Quality Assurance Associate. This position, in the Manufacturing Quality Assurance department, requires a Bachelor’s degree or higher in a scientific or engineering discipline...
-
Quality Assurance Associate
4 days ago
Wilmington, NC, United States Quality Chemical Laboratories Full timeQuality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing laboratory in Wilmington, is seeking a qualified candidate for the position of Manufacturing Quality Assurance Associate. This position, in the Manufacturing Quality Assurance department, requires a Bachelor’s degree or higher in a scientific or engineering discipline...
-
Quality Assurance Associate
2 weeks ago
Wilmington, NC, United States Quality Chemical Laboratories Full timeQuality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing laboratory in Wilmington, is seeking a qualified candidate for the position of Manufacturing Quality Assurance Associate. This position, in the Manufacturing Quality Assurance department, requires a Bachelor’s degree or higher in a scientific or engineering discipline...
-
Quality Assurance Associate
2 weeks ago
Wilmington, NC, United States Quality Chemical Laboratories Full timeQuality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing laboratory in Wilmington, is seeking a qualified candidate for the position of Manufacturing Quality Assurance Associate. This position, in the Manufacturing Quality Assurance department, requires a Bachelor’s degree or higher in a scientific or engineering discipline...
-
Quality Assurance Associate
2 weeks ago
Wilmington, NC, United States Quality Chemical Laboratories Full timeQuality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing laboratory in Wilmington, is seeking a qualified candidate for the position of Manufacturing Quality Assurance Associate. This position, in the Manufacturing Quality Assurance department, requires a Bachelor’s degree or higher in a scientific or engineering discipline...
-
Quality Assurance Associate
2 weeks ago
Wilmington, NC, United States Quality Chemical Laboratories Full timeQuality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing laboratory in Wilmington, is seeking a qualified candidate for the position of Manufacturing Quality Assurance Associate. This position, in the Manufacturing Quality Assurance department, requires a Bachelor’s degree or higher in a scientific or engineering discipline...
