Sr. Supplier Quality Engineer

Reports to: VP, Quality Assurance & Regulatory Affairs
Status: Regular, Exempt

Redmond, WA

Job Summary:

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

Pay Range:

Salary $125K – $135K plus annual bonus

Position Responsibilities:
  • Supplier management process owner
  • Create and manage supplier audit schedule. Conduct supplier audits including travel to key supplier sites.
  • Establish (define, document and implement) 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.
  • Support timely resolution of supply/material related production interruptions.
  • Knowledge of sterilization process and sterilization validation.
  • Review and approve component drawings and qualification plans/protocols.
  • Create and/or review component failure mode and effect analysis (FMEA) working with cross-functional team.
  • Facilitate material/supplier corrective and preventive action (CAPA) investigations.
  • Establish (define, document and implement), review, provide feedback and approve quality system documentation.
  • Contribute supplier related data/information 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 21 CFR Part 820
  • Full understanding of ISO 17025 for testing and calibration laboratories
  • Full understanding of ISO 14971 safety risk management practices
  • 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 both internally and externally
  • 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).
  • Proficiency with planning and problem-solving tools including brainstorming, 5-whys, fish-bone (Ishikawa) diagramming, flow charts, Pareto charts, control charts, etc.
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: