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]
