Sr. Quality Compliance Engineer

Reports to: VP, Quality Assurance & Regulatory Affairs
Status: Regular, Full-time, Exempt, Redmond, WA

Redmond, WA

Job Summary:

As Sr. Quality Compliance Engineer, you will be responsible for Quality Compliance and Supplier Engineer activities. You will work closely with several functions including R&D, Regulatory, Clinical, and Operations/Manufacturing in assisting and supporting continuous improvement activities and ensuring compliance with the requirements of the following standards: ISO 13485, MDSAP, FDA 21 CFR Part 820, MDD, and EU MDR and other applicable standards.

Pay Range:

Salary Range: $130,000 to $140,000

Position Responsibilities:
  • Supplier management process owner including creating and managing supplier audit schedule. Contributing supplier-related data/information to ongoing monthly Quality reviews and quarterly Quality Management Review meetings.
  • Support medical device reporting assessments and investigations requiring working experience with quality and regulatory standards, including but not limited to FDA 21 CFR Part 820, 21 CFR Part 803, ISO 13485:2016, and ISO 14971 (Risk Management for Medical Devices).
  • Experience with the Post-Market Surveillance Analyst to monitor, analyze, and trend complaints. Assist with the complaint process including coordinating with and gathering sufficient data from customers, field representatives, internal staff, and outside experts.
  • Experience with NCRs, MRB, Complaint and Corrective and Preventive action activities to support other Quality Engineers in the team as required.
  • Participate in performing internal and external audits to ensure compliance.
Position Qualifications:
  • BSME or equivalent experience in a medical device environment
  • Five or more years of 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.)
  • Effective communication, and ability to work both independently and in a team environment and to present detailed technical data both internally and externally.
  • Effective oral/written communication 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).
  • Working Experience within ISO 13485:2016, ISP 14971, GMP guidelines, FDA CFR820, European MDD/MDR, and MDSAP.
  • Knowledge of global regulations for medical device reporting and terminology is a plus.
  • Able to handle multiple tasks in a fast-paced, results-oriented environment.
  • Excellent data entry and analysis skills.
  • Self-motivated and result-driven attitude and strong problem-solving skills.
  • Working knowledge of Microsoft Word, Excel, PowerPoint, and Project.
Equipment to be used in Performance of Job:
  • Computer and printer
  • Fax Machine
  • Copier Equipment
  • General Office Equipment
  • Enterprise software solutions, e.g., Agile, QAD
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: