Senior Quality Assurance Associate
Secure BioMed Evaluations
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Senior Quality Assurance Associate

Secure BioMed Evaluations

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Details
Posted:
March 11, 2021
Location:
Woodstock, Georgia
PayScale
Type:
Full Time - Experienced
Categories:
Quality, Quality Engineering

Essential Functions, Duties and Responsibilities: 

  • Report to Executive VP of Quality on a regular basis regarding status of ongoing projects
  • Ensure Smartsheet (project management cloud based software) accurately reflects timelines and responsibility assignment
  • Support quality compliance needs from design control through commercial distribution.
  • Coordinate and/or directly review and approve design history files, device master records, and device history record documentation.
  • Working with engineering to develop, review and approve verification and validation protocols, work instructions, forms and reports.
  • Facilitate initiation and closure of CAPAs, complaints, and NCRs
  • Compile and institute quality metrics to present at management review meetings to trend, recommend, and implement corrective actions and appropriate follow-up, when necessary.
  • Support audits as a subject matter expert on quality assurance/engineering documentation

Travel Requirements:

  • Travel is occasionally required and would include both supplier audits and onsite client support for quality system implementation.

Minimum Required Education & Experience:

  • BS Degree in engineering or science
  • 5+ years of experience working in Quality Assurance, preferably in the medical device industry

Preferred:

  • Knowledge of ISO 13485 and other recognized international quality system standards.
  • Knowledge of FDA CFR 820.
  • Experience leading audits as part of supplier control.

About Secure BioMed Evaluations
Secure BioMed Evaluations is a rapidly growing consulting firm providing engineering, regulatory, and quality support to the medical device and biologics community. Headquartered in Woodstock, GA, we offer a rewarding work environment with global opportunities while maintaining a small company, employee-focused atmosphere. We are currently searching for a dynamic individual to join our Quality Assurance Team. SBME team members need to work well in a team, have great customer service skills, and have the ability to create and edit technical documentation. Please submit resumes to [email protected]
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