Job Details


Biomedical


Quality Engineer  Redmond, WA  Posted: 4/29/2021
Job Description

Job Number:

312118

Category:

Biomedical


Details:

A Quality Engineer job in Redmond, WA is currently available through Belcan. In the Quality Engineer role you will perform the primary duties supporting various quality engineering responsibilities on the manufacturing floor and within the Quality Department for data trending and reporting for various tasks..
Quality Engineer job duties:
* 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 R&R)
* 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
EDUCATION AND EXPERIENCE REQUIRED:

* 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
If you are interested in this Quality Engineer role located in Redmond, WA please apply via the 'apply now' link provided.

Belcan is a global supplier of engineering, technical recruiting, and IT services to customers in the aerospace, industrial, and government sectors. Belcan engineers" better outcomes through adaptive and integrated services-from jet engines, airframe, and avionics to heavy vehicles, chemical processing, and cybersecurity. Belcan takes a partnering approach to provide customer-driven solutions that are flexible, scalable, and cost-effective. Our unique capabilities have led to continuous growth and success for over 60 years. We are a team-driven Equal Opportunity Employer committed to workforce diversity. All qualified applicants will receive consideration for employment without regard to status as a protected veteran or a qualified individual with a disability, or other protected status such as race, religion, color, national origin, sex, sexual orientation, gender identity, genetic information, pregnancy or age.


 



 

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