Principal Supplier Quality Engineer

6 days ago

Trumbull, United States Cooper Companies Full time

Job Description

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. CooperSurgical is at the forefront of delivering innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the benefit of families. We currently offer over 600 clinically relevant medical devices to women's healthcare providers, including testing and treatment options.

CooperSurgical is a wholly-owned subsidiary of CooperCompanies (Nasdaq: COO). CooperSurgical, headquartered in Trumbull, CT, produces and markets a wide array of products and services for use by women's health care clinicians. More information can be found at www.coopersurgical.com.

Responsibilities

Full knowledge of and understanding of PPAP, IQ, OQ, PQ and validation activities Lead and determine correct PPAP levels with the ability to write protocols of IQ, OQ, PQ and PPAP checklist and warrants. Full knowledge, application and management of Supplier Quality sustaining and strategic activities Knowledge and full understanding of the medical device requirements (e.g., FDA QSR, ISO 13485, EU MDR, CMDCAS and etc..). Support transfer projects and Supplier localization projects. Other possible activities are those listed below.

Facilitates the supplier compliance program (Site audit, drive improvement in supplier performance, supplier development, supplier selection and qualification). 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. 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 Supports internal and external QMS audits. And works as a key player in the audit's backup rooms or inspection rooms. Files and maintains Supplier related documentation as per QMS. 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. Works and leads collaborative activities with Quality Engineers, Inspectors, Value Streams as well as Purchasing, Engineering teams. 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. Performs additional assignments as required by management. Create a critical review of supplier strategies and segmentation strategies. Travel:

20% to 50%

#LL-DD1

Qualifications

Bachelor's degree / Master's degree Black Belt a plus Certified Quality Engineer, Certified Reliability Engineer a plus Minimum 7 to 10 years of related experience in PPAP and IQ, OQ, PQ validations. 5 to 7 years in regulated quality environment.

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. #J-18808-Ljbffr

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