Supplier Quality Engineer/Assurance

About CooperSurgical

CooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com. 

Work location: Trumbull, CT (on-site)

Scope: 

Job Summary:

• Lead SCAR, SCN and Supplier Nonconformance processes
• Supplier Development activities
• Risk Assessments

Essential Functions & Accountabilities:

1. Manage Supplier Quality sustaining activities. 

2. Other possible activities are those listed below. 

   1. Facilitates the supplier compliance program (Site audit, drive improvement in supplier performance, supplier development, supplier selection and qualification).

   2. Acts as a quality assurance consultant in the development and implementation of quality systems in compliance with FDA QSR, ISO 13485, MDD and CMDCAS and other relevant requirements at partner suppliers/vendors in order to support operations and development engineering.

   3. Works with Value Streams once Engineering and Quality Engineering; confirm there is a Supplier related improvement opportunity or Non-Conforming Material Reports (NCMRs).

3. Supports development and implementation of supplier quality program by doing the following:

a.  Support supplier on-going monitoring and re-evaluation process.

b. Manage Supplier SCAR / CAPA / NCR and periodically provide metrics/report to Management Review Process.

c. Create/ Maintain supplier quality agreements.

d. Support all Procurement supplier Projects.

e. Support all new Product Development that is intended for production at suppliers.

f. Support all business continuity projects at suppliers.

g. Update SOPs and Forms related to supplier management process as needed

1. Supports internal and external QMS audits. And works as a key player in the audit’s backup rooms or inspection rooms.

2. Files and maintains Supplier related documentation as per QMS.

3. Perform supplier audits, conduct supplier site visits as needed to identify systemic gaps in performance expectations at suppliers and implement mitigating processes at Cooper sites, as needed.

4. Collaborates with Quality Engineers, Inspectors, Value Streams as well as Purchasing teams.

5. When required, submits Supplier Corrective Action Requests (SCAR) for Supplier related NCMRs. And reviews Supplier responses for appropriate root cause analysis and Corrective Actions to prevent re-occurrence of failure modes.

   Support supplier validation activities as required from Supplier Quality prospective. 

6. Support transfer projects and Supplier localization projects.

7. Support IQ, OQ, PQ and PPAP processes

8. Performs additional assignments as required by management.

Travel: 

10% to 25%

Qualifications

Knowledge, Skills and Abilities:

1. Knowledge of FDA QSR, ISO 13485, EUMDR, ISO 14971

2. Knowledge and experience with a regulated Supplier Management process

3. Previous experience in supply chain, auditing, verification, and validation.

4. Previous experience with Change Control Systems, FDA QSRs and ISO 13485.

5. Excellent verbal and written communication skills and strong organizational skills

6. Bachelor’s Degree in Chemical, Electro-Mechanical, Industrial, Bioprocess Engineering or related to Life Science field or equivalent experience or skill sets.  CQE, APICS, Green Belt or Black Belt certifications are a plus.

7. 5 or more years of related experience in a regulated quality environment.

8. Advance level of English speaking and writing. Traveling experience is a plus.

9. With previous experience negotiating with Suppliers.

10. Computer skills, MS Office, Minitab, and previous experience with ERP and QMS systems.

11. Passing of background check, which may include verification of prior employment, criminal conviction history, education and driving records.

12. Understanding, knowledge and application of relevant processes and the various cost drivers per market, commodity or segment. 

13. Previous experience in supply chain, auditing, verification, and validation, GD&T.

14. Previous experience with Change Control Systems and Design Control.

15. Excellent verbal and written communication skills and strong organizational skills

16. Advance level of English speaking and writing. Traveling experience is a plus.

17. Computer skills, MS Office, Minitab, and previous experience with ERP and QMS systems.

18. Passing of background check, which may include verification of prior employment, criminal conviction history, education and driving records.

Experience:

• 3 to 5 years in regulated quality environment.

• 3 to 5 years in working with Supplier Management processes

Education:

• Bachelor’s Degree in Chemical, Electro-Mechanical, Industrial, Bioprocess Engineering or related to Life Science field or equivalent experience or skill sets.  CQE, APICS, Green Belt or Black Belt certifications are a plus.

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Our Benefits:

As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits. Please visit us at www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team.

To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.

We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.