21 days old

Sr. Quality Engineer

Kelly Services
Westlake Village, CA 91361
**JOB SUMMARY: Medical Device experience required**

The Senior Quality Engineer is responsible for performing a wide range of Quality Engineering activities, with the purpose of supporting the Regulatory, R&D, Quality and Manufacturing departments. The incumbent for this position will support various engineering support duties including, (but not limited to), design verification and validations, test method validations, process validations, software validations, equipment qualifications IQ/OQ/PQ, and play a crucial part in leading a seamless transition from the design phase into production for all new products and product sustaining projects. Furthermore, incumbent for this position needs to ensure that the Risk Management process is followed and supports the management of standards and guidance.


1. Work closely with Regulatory, R&D, Quality and Manufacturing, to ensure the highest quality products and processes are being developed and deployed.

2. Ensure that process and equipment improvements/upgrades are properly validated, and placed into production so that resulting product can be produced with the required quality and repeatability.

3. Perform/support engineering analysis of the product performance post-market release using quality inputs such as external defect rates, returns, and line rejects, customer feedback, feedback from regulators, and observations from audits/inspections.

4. Provide leadership/support and direction for activities supporting complaint and CAPA investigations; ensure timely completion with all assigned activities.

5. Provide leadership/support and be accountable for support for CAPAs, Health Hazard Evaluations, Field Corrective Actions, Nonconforming Materials processes, and quality systems related responsibilities.

6. Lead/Participate in internal quality audits.

7. Lead/Participate in Risk analysis and management.

8. Deploy and utilize Statistical Process Control (SPC), where applicable.

9. Assist in the development and implementation of final product testing.

10. Perform statistical sampling, as needed, to ensure product quality and process performance.

11. Support the onboarding of new suppliers (supplier audits included)

12. Support MRB and NCMR evaluation, investigation and dispositions

**MINIMUM REQUIREMENTS:** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


+ Bachelor of Science in Engineering or related Engineering field required.

+ Minimum 5 years in QE role in product design and development, preferably in a Class II or III medical device environment.

+ Solid understanding of design control, US FDA QSR, ISO 13485, EU MDD/MDR, MDSAP, CMDCAS, Brazil RD, Australia TGA, Japan PAL, ISO 14971 and other applicable standards and regulations.

+ Working knowledge of statistics and statistical packages (MiniTab) and design software (solid works).


+ Master degree

+ Regulatory Affairs Certification (RAC) or CQE (Certified Quality Engineer) preferred

+ Proven experience with lean manufacturing and six sigma processes

+ Experience related to the regulation of Class II and III medical devices

+ Knowledge of clean room and terminal sterilization processes and requirements

**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.
Posted: 2021-05-28 Expires: 2021-06-28

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Sr. Quality Engineer

Kelly Services
Westlake Village, CA 91361

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