Careers

Sr. Supplier Development/Quality Engineer

Reports to: Sr. Director, Quality Assurance & Regulatory Affairs
Status: Regular, Exempt
Location: Redmond
Job Summary:

Quality Engineer with duties supporting supplier development, quality management and change management within the Quality Department.

Position Responsibilities:
  • Create and manage Supplier Audit Schedule. Conduct Supplier Audits.
  • Develop and maintain supplier qualification requirements.
  • Own supplier changes and lead internal cross-functional efforts.
  • Create supplier/component qualification plans and reports for new suppliers and supplier changes.
  • Knowledge of sterilization process and sterilization validation.
  • Review and approve component drawings and qualification plans.
  • Create and/or review component failure mode and effect analysis (FMEA) working with cross-functional team.
  • Handle Corrective and Preventive Action (CAPA) investigations.
  • Develop, review, provide feedback and approve quality system documentation.
  • Contribute to ongoing monthly quality review and quarterly Quality Management Review meetings.
Position Qualifications:
  • BSME or equivalent experience in a medical device environment
  • Five or more years relevant medical device industry experience
  • Sound understanding of quality assurance concepts
  • Full understanding of ISO 13485 and FDA 21CFR820
  • Ability to lead quality and supplier interaction meetings
  • Full understanding of part qualification processes
  • ASQ Certification a plus (e.g. CQA, CQIA, CQT, CQPA, CQE, etc.)
  • Strong communication, interpersonal and problem-solving skills with ability to work both independently and in a team environment and to present detailed technical data to internal personnel
  • Effective oral/written communications skills with preferences in technical writing, presentations, reports, data analysis, etc.
  • Experience with sterile disposable devices a plus
  • Proficient in analyzing product data to perform statistical and trend reporting
  • Proficiency with Quality tools/methodologies including: Design Control, Risk Analysis (Hazard Analysis), Design FMEA, Process FMEA, Statistical Analysis, DOE and MSA (Gauge R&R).
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.

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.

All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or protected veteran status. EndoGastric Solutions takes affirmative action in support of its policy to employ and advance in employment individuals who are minorities, women, protected veterans, and individuals with disabilities.

Interested candidates should submit their resume and cover letter to Human Resources:
hr@endogastricsolutions.com