Quality Engineer Seattle, WA Posted: 3/22/2021
A Quality Engineer role located in Seattle, WA is currently available through Belcan. The Quality Engineer will own the mechanical engineering design of select new products. As an engineering owner, you will assume ownership of all quality engineering project tasks and deliverables, and manage the Hardware and Software verification process for our client projects. You must be able to integrate with the team, working in tandem with design and all engineering disciplines, and be an engineering leader.
Quality Engineer duties:
* Interpret and articulate FDA and other regulatory requirements for medical devices.
* Plan and execute quality engineering activities that comply with regulatory requirements and
industry best practices.
* Develop requirement specifications at both system and design levels.
* Develop verification test plans protocols, and verification summary reports.
* Train personnel assigned to generate or execute verification test protocols.
* Develop risk management plans, performing risk/hazard analysis, fault tree analysis, and failure
modes ad effects analysis.
EDUCATION AND EXPERIENCE REQUIRED:
* BS degree in Engineering ME, EE, SW, Computer Science, or related equivalent experience
* Experience in quality engineering tasks associated with product development of medical devices,
or five years equivalent related experience.
* Working knowledge of 21 CFR 820 Quality System Regulation for Medical Devices, ISO 13485
Quality System Requirements for Regulatory purposes, and ISO 14971, Medical Devices-
Application of Risk Management to Medical Devices.
* Working knowledge of IEC 60601-1, Medical Electrical Equipment, IEC 61010-1 Safety
requirements for electrical equipment for measurement, control, and laboratory use, and IEC
62304, medical device Software-Software life cycle processes.
* Ability to interpret and articulate FDA and other regulatory requirements for medical devices.
* Auditor certificate for ISO 13485 and/or AS9100 desired.
* Familiarity with appropriate electronics design for consumer, industrial or medical products is
* Familiarity with consumer, industrial or medical device Software-Software life cycle processes.
If you are interested in this Quality Engineer role located in Seattle, 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.