Quality Systems Engineer from Boston Group Executive Offices

Boston, MA 02103

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.

 

 

COMPANY INFO:

 

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.

 

JOB DESCRIPTION:

 

·         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.

 

QUALIFICATIONS:

 

·         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: jkroehler@mri-boston.com

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