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EsophyX (EndoGastric Solutions, Inc.) Quality Engineer in Redmond, Washington

Title: Quality Engineer (Work In Process)Reports to: Director, Quality AssuranceStatus: Regular, Full-time, Exempt, Redmond, WA Job Summary: Work-In-Process Quality Engineer with primary duties supporting various quality engineering responsibilities on the manufacturing floor and within the Quality Department for data trending and reporting for various tasks. Position Responsibilities: *Participate and/or conduct Corrective and Preventive Action (CAPA) investigations and manufacturing process audits. *Review and approve manufacturing tooling drawings and manufacturing work instructions. *Investigate and take corrective action for manufacturing nonconformance reports. *Mentor, review and approve manufacturing process validation plans, protocols and reports generated by manufacturing teams. *Owner of complaint handling process including complaint intake, failure analysis of returned devices, documenting findings, risk assessment and complaint file closure. *Ownership to submit FDA, Medical Device/Vigilance Reports, as necessary. *Coordinate with supplier QE and Receiving Inspection personnel when manufacturing issues arise. *Demonstrate use of Quality tools/methodologies including: Design Control, Risk Analysis (Hazard Analysis), Design FMEA, Process FMEA, Statistical Analysis, DOE and MSA (Gauge RandR). *Support Design/Change Control requirements consistent with regulatory and EGS procedures. *Mentor, review and approve manufacturing process FMEAs developed by manufacturing teams. *Mentor, review and approve in-process, and final acceptance activity requirements developed by engineering and/or manufacturing teams. *Develop, review, provide feedback and approve quality system documentation *Contribute significantly to ongoing quality reviews, including Quality Management Review. Position Qualifications: *Prefer bachelor’s degree in Engineering or Science related discipline *Five or more years relevant medical device industry experience *Sound understanding of quality assurance concepts *Full understanding of ISO 13485 and FDA 21CFR820 *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