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:

Under the direction of the Manager, Supplier Quality, this position is responsible to support all functions of Global Supplier Quality Program are consistently in compliance with regulatory requirements and corporate standards.

Ensures that quality standards are met by all suppliers to CooperSurgical.

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 iden...