Quality Engineering Manager

Quality Engineering Manager

 

EndoGastric Solutions, Inc. is a fast-growth medical technology company headquartered in Redmond, Washington.  The company is revolutionizing the fields of upper gastroenterology diseases including gastroesophageal reflux disease (GERD) and other GI disorders.

 

We currently have an opportunity for a Quality Engineering Manager who will provide quality leadership and support cross-functional teams in identifying factors affecting product and process quality.  The engineer/manager will be responsible for the following activities:

 

· The definitive resource for all FDA quality system regulation and ISO13485:2003 quality management system related questions

· Chair Receiving Inspection and Manufacturing Material Review Boards

· Improve risk analysis processes and procedure using ISO 14971:2007

· Review and approve all engineering and quality system change documentation

· Mentor, review and approve verification and validation plans, protocols and reports generated by engineering teams

· Mentor, review and approve manufacturing process validation plans, protocols and reports generated by manufacturing teams

· Mentor, review and approve manufacturing process FMEAs developed by manufacturing teams

· Mentor, review and approve receiving, in-process and final acceptance activity requirements

· Research new safety and environmental standard decisions or rulings

· Participate in the Corrective and Preventive Action System (CAPA) process and contribute to ongoing quality review including Quality Management Review

· Other assignments as directed

 

Position Requirements:

 

· Prefer BSME or equivalent experience in a medical device environment

· Thorough knowledge of USFDA, 21CFR820 Quality System and ISO13485:2003 regulations

· Ten or more years of Quality Engineering experience in a medical device manufacturing environment

· Minimum two years Quality management/supervisory experience

· Excellent written and verbal communication skills including ability to communicate technical information

· Thorough knowledge of quality and reliability design principles

· Prefer experience with sterile disposable devices

· Proficient in analyzing product data to perform statistical and trend reporting

· Familiar with inspection/test development

· Certified Quality Engineer (CQE) preferred

 

EndoGastric Solutions, Inc. is committed to recruiting individuals who believe in team work, achievement and excellence.  We strive to attract and retain employees of the highest caliber based on abilities, achievements and experience.

 

Interested candidates should submit their resumes to Human Resources:

 

Email cover letter and resume:

 

hr@endogastricsolutions.com

 

Company website:

 

www.endogastricsolutions.com