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15 days old

Principal Quality Engineer

Kelly Services
Snoqualmie, WA 98065
Principal Quality Engineer needed for innovative healthcare technology company based out of Snoqualmie, WA to drive projects and programs to eliminate and mitigate product and process related issues associated with sustaining engineering of current products globally.


Remote candidates considered but must be willing to travel to work on-site for one week every other month. Email resume with Principal Quality Engineer in subject line to Hannah.niblett@kellyengineering.com .


**Responsibilities:**


+ Detailed data analysis of manufacturing efficiency.

+ Field product performance monitoring and trend data.

+ Process development and ownership.

+ Change management leadership.

+ Support of new product launches to assure a successful implementation.

+ Drive process improvements in Receiving Inspection Plans.

+ Defining Critical to Quality attributes in specification.

+ Owning production quality master data within the Enterprise Resource Planning (ERP) tool.

+ Supports multiple business units and company sites globally.

+ Direct and / or indirect personnel management may be required on a project basis.


Qualifications:


+ Required Bachelor s degree in an engineering discipline, Mechanical, Electrical, Software/ Computer, Biomedical, Industrial, Manufacturing ,5 years of directly related experience may be substituted for the educational requirement.

+ 10+ years in quality engineering. 5+ years of experience with medical device regulatory and quality systems.

+ Strong working knowledge of software development process.

+ Experience maintaining metadata within an ERP System.

+ Subject Matter Expert in Root Cause Analysis and Investigations.

+ Expert in production Verification and Validation, Statistical Process Controls SPC, and Design of Experiments DOE.

+ Experience establishing Risk Management Files, Usability Engineering Files, Design History Files, MVP s, and Change Control documentation.

+ Experience reading, interpreting, and updating CAD Drawings.

+ Experience with statistical analysis and data mining.

+ Knowledge of Software as a Medical Device SaMD or Software within a device required.

+ Experience addressing questions during internal/ external audits.

+ Desirable ASQ certified quality engineer CQE and/or black belt certification.

+ Experience establishing MDD, MDR, EN ISO 13485, EN ISO 14971, EN 62304, EN 62366-1, Cybersecurity, 60601, and 14001 preferred.

+ Success implementing Capability Maturity Models CMMi, swCMM .

+ Creative problem solving, flexibility, and good negotiation skills.

+ Proven ability to communicate effectively with staff at all levels of the organization.

+ Ability to multi-task and drive practical results to a timely conclusion.

+ Some travel may be necessary both domestic and international, less than 10%.


Company COVID-19 Vaccine Policy To comply with applicable government requirements, all U.S. employees must be fully vaccinated against COVID-19 unless they are entitled to and approved for a legal accommodation, in accordance with the Company s COVID-19 Vaccination Policy.


Email resume with Principal Quality Engineer in subject line to Hannah.niblett@kellyengineering.com .


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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Posted: 2021-11-12 Expires: 2021-12-13

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Principal Quality Engineer

Kelly Services
Snoqualmie, WA 98065

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