Hybrid: Lead Auditor / Quality Manager (235190)

Life Sciences & Technology
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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)

#LI-Hybrid

About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Start Date
ASAP
State
Massachusetts
Location
US On-Site

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