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25 days old

Process Quality Assurance Engineer

Kelly Services
Añasco, PR 00610
**Process Quality Assurance Engineer**


To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.


1. Develop and implement SPC control system with Manufacturing and Quality Control.

2. Develop statistically based sampling plans for in-process and final testing and inspections, and validations.

3. Work with project teams to develop Design of Experiments (DOEs) and statistically sound tests for appropriate support of results.

4. Review and approve validations and completion reports for new and existing products, processes and equipment. Provide statistical analysis of the data to support the reports.

5. Prepare information for Management Reviews, conduct Vendor Audits, perform and complete Complaint Investigations, and prepare reports.

6. Ensure that all projects are in compliance with QSR (including Design Controls), ISO or other applicable requirements.

7. Participates in FDA inspections, ISO Certification and surveillance audits and customer audits as required.

8. Support corporate Regulatory Affairs by providing information for submissions and Annual Reports.

9. Identify and implement opportunities for continuous improvement.

10. Interact and coordinate activities with other departments, external vendors and customers.

11. Maintain fiscal responsibility and budget compliance.

12. Perform other related duties as required.


**Requirements:**


The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.


+ Bachelor Degree in Engineering or science.

+ Certified Quality Engineer (CQE) preferred.

+ 3 to 5 years experience in an FDA regulated environment.

+ Demonstrates excellent knowledge of statistical sampling and analysis, including DOE design.

+ Demonstrates excellent organizational and communication skills and proficiency with MS Word and Excel and statistical software


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


Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the worlds most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, were here to guide you to the next step in your engineering career.


**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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

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Posted: 2022-07-25 Expires: 2022-09-08

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Process Quality Assurance Engineer

Kelly Services
Añasco, PR 00610

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