Location
- Waltham, 3 days a week or Gaithersburg, MD
Duration
- 6 months, contract to perm option.
Job Description
- Our medical device client needs a Lead Auditor that can also serve as Quality Manager. Must have auditor training and preferably certification, been in regulatory audits, performed mock audits, been through audits and 483 responses and lead remediation’s. Must have experience updating quality manuals, someone who can manage the room, take possibly hostile questions from auditors and drive the team to the right response. Must have medical device experience and possibly SaMD experience. Large company experience wanted for this. Degree is a must. Must come from quality, previously software, possibly programming or coding experience previously. FDA, BSI, TÜV SÜD, DEKA audits, ISO 62304, 62366, 60601, 13485 and EU MDR audits. Plus if person has some machine learning/AI, 510(k), PMA, sPMA experience. Experience with clinical trial software specifically SaMD would be helpful. 10+ years experience wanted for this. This is a 40 hour per week position balancing auditing and Quality Management.
Skills
- Lead Auditor, Medical Devices, Quality
Education
- Degreed engineer and preference for auditor certification.
Hybrid: Lead Auditor / Quality Manager (235190)
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