16 days old

Quality Engineer

Kelly Services
Schaumburg, IL 60173
Kelly Engineering Resources is searching for a Quality Engineer on behalf of our client a pharma/medical device manufacturer. In this role, you will report to the Quality Manager and lead quality efforts for new product testing, test method development, process and design validation, data analysis, competitive testing and contribute to other quality improvement projects.

Our client offers BC/BS of IL, Dental, Vision, FSA, Pet Insurance, 2 weeks PTO, Sick time

**Essential Responsibilities**

1. Participate in the product development process as required to ensure that customer requirements are met.

2. Perform product validation testing, develop test methods, protocols, and issue reports as needed.

3. Support the process and product FMEA, and Risk Management activities.

4. Monitor and analyze effectiveness of process controls in support of validation maintenance.

5. Lead and facilitate CAPA project teams as required to ensure continuous quality improvement.

6. Assume the facility customer complaint responsibilities regarding failure analysis, root-cause investigation, and corrective action as required per corporate policy.

7. Participate in the development, execution, analysis and reporting of first-article qualification and process validations both internally and suppliers facilities as required.

8. Perform and document equipment and process Capability Studies.

9. Conduct analytical testing and root cause analysis for process nonconformance.

10. Develop and prepare facility quality performance reports, charts, and graphs as needed for management decision making.

11. Conduct comparative tests on competitive products, issue evaluation reports.

12. Lead six sigma projects

13. Provide technical leadership for the quality team

14. Support the internal auditing program. ISO 9001 & ISO 13485

15. Other duties as assigned by the Quality Management.

**Qualifications of the Successful Quality Engineer**

+ Bachelor of Science in Engineering, Science or Mathematics required, Six Sigma training/certifications a plus

+ 3+ years of Quality Control experience in a medical device manufacturing facility that includes:

+ Familiarity with quality engineering methods.

+ Excellent computer skills including experience with MS Office applications.

+ Working knowledge of FDA regulations and ISO 13485 standard.

+ Product testing or validation experience a plus

+ Must possess excellent written and verbal communication skills, team facilitation skills, advanced problem-solving skills, and the ability to communicate effectively with all levels within the organization.

+ Proficient with MS Office required, using databases, spreadsheets and statistical software such Minitab


+ Management: the ability to organize and manage multiple priorities.

+ Ability to communicate, interact and work effectively with people from diverse ethnic and educational backgrounds, as well as across all levels of the organization


**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: 2022-05-09 Expires: 2022-06-09

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Quality Engineer

Kelly Services
Schaumburg, IL 60173

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