26 days old

Quality Engineer

Kelly Services
Campbell, CA 95009
**Senior Quality Engineer**

Kelly Engineering Resources has an outstanding **Contract-to-Hire** opportunity for a **Senior** **Quality Engineer.** 5 years of experience in the Medical Device industry is required, to include thorough regulatory knowledge of IS0 13485 guidelines. Project management experience is a major plus. The facility in Campbell is a contract manufacturing facility specializing in balloon catheter volume production but also supports additional product lines.

**Job Duties of the Senior Quality Engineer:**

+ Implementation of quality system documentation that is in compliance with the quality manual and associated Standard Operating Procedures (SOPs).

+ Develop and execute to Validation Master Plans, Equipment Qualifications, Process Validations, and test method validations for successful transfer from development to manufacturing working in a cross-functional group.

+ Develop and maintain the PFMEA process for manufacturing.

+ Support/participate in regulatory agency and customer quality audits.

+ Participate in design control activities to ensure that product meet specifications, reliability, and manufacturability.

+ Working knowledge of CAPA management to drive to root cause analysis and practical corrective and preventive solutions. Utilize formal problem- solving techniques to resolve product and/or process related issues.

+ Write and or assist in development of protocols, technical investigation plans, engineering reports, and related procedures which ensure statistical validity, adequacy, and compliance to regulatory and corporate requirements.

+ Working knowledge of concepts of probability and statistics as well as aide in updating/establishing SPC and Gage R&R studies.

+ Work with suppliers of both raw materials and components to improve product quality and/or resolve quality issues.

+ Provides problem solving support, clarification of process performance requirements, to successfully complete assigned tasks as directed.

+ Manage project transfers related activities

+ Works with other Quality Engineers to ensure that

+ Quality Problems are detected and corrected in the earliest stages of production

+ Quality Problems are not transferred to our customer

**Qualifications of the Senior Quality Engineer:**

+ BS/BA degree with a scientific/engineering emphasis required.

+ AQS Certified Quality Engineer or MS degree desirable

+ Six Sigma Green/Black belt recommended

+ Minimum of 5 years experience in a related regulated medical device environment. Catheter/MI experiences an advantage.

Apply today for immediate consideration

**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/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. 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.


Posted: 2020-08-24 Expires: 2020-09-24

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Quality Engineer

Kelly Services
Campbell, CA 95009

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