Jobid=7e59252bbdf9 (0.0142)
ppbExclusively on behalf of our partner AMT Medical, Unity Partners is looking for a Quality Engineer Production. /b /p pAMT Medical is a pioneering medical device company developing a transformative heart bypass procedure. With its groundbreaking Elana Anastomotic System, AMT aims to revolutionize Coronary Artery Bypass Surgery (CABG). This minimally invasive technology enables surgeons to create a sutureless bypass on a beating heart—without a heart‑lung machine—reducing patient impact and accelerating recovery. /p pbAs Quality Engineer – Production /b, you will take ownership of quality assurance across our manufacturing activities for Class III cardiovascular devices. You will play a key role in ensuring compliant, efficient, and high‑quality production processes in a cleanroom environment. From validation to supplier quality, inspection, and continuous improvement, this is a hands‑on position with strategic influence. /p h3Key Responsibilities /h3 ul liLead bprocess validation /b (IQ/OQ/PQ) for both new and existing production processes. /li liOversee bquality control and inspection activities /b, develop sampling plans, and resolve complex QC challenges. /li liManage and improve the bsupplier quality system /b, including audits, SCARs, and qualification of new suppliers. /li liDrive bCAPA and nonconformance investigations /b, using structured root cause analysis (Lean/Six Sigma). /li liEnsure full compliance with bFDA 21 CFR 820, ISO 13485 /b, and bMDR /b requirements. /li liCollaborate with production, engineering, and procurement teams to embed a strong quality culture. /li liMentor operators and staff in regulatory expectations, procedures, and quality best practices. /li /ul h3What You Bring /h3 ul liA bBachelor’s degree /b in Engineering or a related technical/scientific discipline (Master’s a plus). /li lib5+ years /b of experience in QA within the bmedical device industry /b, preferably with bClass III /b devices. /li liDeep experience with bmanufacturing process validation /b and working in bcleanroom /b environments. /li liStrong expertise in bsupplier quality management /b, quality control, and statistical techniques. /liliIn‑depth knowledge of relevant regulations: bISO 13485 /b, bFDA QSR /b, bMDR /b, and bISO 14971 /b. /li liStrong communication skills and a hands‑on mindset with a drive for results. /li liComfortable working in a fast‑paced, scaling environment with high impact. /li /ul h3Organization Offer /h3 pYou’ll join a fast‑growing scale‑up at the cutting edge of cardiac care innovation. With clinical trials already underway and growing international traction, your role will have immediate and visible impact. Expect a bcollaborative work culture /b, bcompetitive salary benefits /b, and strong support for bprofessional development and leadership growth /b. /p h3INTERESTED? /h3 pReach out to bChristian Steenkamp /b via or +31 (0) for more information or apply directly. /p h3Seniority level /h3 ulliMid‑Senior level /li /ul h3Employment type /h3 ulliFull‑time /li /ul h3Job function /h3 ul liQuality Assurance and Engineering /li liMedical Equipment Manufacturing, Manufacturing, and Hospitals and Health Care /li /ul /p #J-18808-Ljbffr
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