Supplier Quality EngineerAssurance

About CooperSurgical

CooperSurgical is a leading fertility and womens 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 were driven by a unified purpose to enable patients to experience lifes 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 womens 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.

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 audits 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. Bachelors 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:

• Bachelors 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 youll 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 atto 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 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.