About the Job
MRINetwork™ is the world's largest executive search and recruitment organization. We have a global network of more than 1,000 offices. Management Recruiters - The Boston Group is our 5 office organization, established in 1966 to provide executive and management level staffing services to a wide variety of industries.
Quality Systems Engineer assignment: Here is an exciting opportunity for a quality professional to maintain and monitor key Quality Systems elements: corrective action/preventive action (CAPA), Internal Audits, Supplier Audits, Procedure Development, Key Metric Reporting, and Quality Training Coordination. Our Client is a market leader in diagnostic instruments, passionate about bringing medical professionals the most valuable and complete solutions for their testing needs. They are a people-driven business, offering a top of the line work environment, the ability to be involved at all levels and the opportunity to work with a first class team. Excellent location, benefits and opportunity to impact the bottom line and career advancement are additional benefits to working with this organization.
· Provide oversight, maintenance and training for all elements of the Quality Systems programs.
· Support supplier qualification, selection and oversight and development of the Approved Supplier List.
· Support the Internal Audit and Supplier Audit programs and provide oversight of the resolution of deficiencies through the CAPA program.
· Support design control processes and monitor Design History Files for accuracy.
· Coordinate the site Quality Training Program.
· Maintain accurate documentation and files related to the Quality Systems programs.
· BS Degree in a Life Science or Engineering,
· 5+ years experience in medical device, including IVD industry ; experience with ISO 13485 and ISO 14971 preferred.
· Proficiency in the application of statistical methods, failure analysis, CAPA, and supplier auditing
· Excellent written and oral communication skills.
· Boston Area residency will be given preference
Keywords: BS/MS, Life Science, medical device, in vitro diagnostics, ISO 13485, 21 CFR Part 820, ISO 14971, auditing, CAPA
Qualified candidates send a Microsoft Word version of your resume to: firstname.lastname@example.org