Quality Engineering S

Supplier Quality Engineer II

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.

Work location: Trumbull, CT or Livingston, NJ (on-site)

Scope: The Supplier Quality Engineer II is responsible for supporting all functions of the Global Supplier Quality Program and to ensure consistency in compliance with regulatory requirements and corporate standards, and that all quality standards are met by suppliers to CooperSurgical.

Job Summary: The Supplier Quality Engineer II is responsible for leading SCAR, SCN and Supplier Nonconformance processes, Supplier Development activities, and Risk Assessments.

Responsibilities

Manage Supplier Quality sustaining activities.

Other possible activities include:

Facilitate the supplier compliance program (site audit, drive improvement in supplier performance, supplier development, supplier selection and qualification).

Act 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.

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

Support development & implementation of supplier quality program by:

Supplier on-going monitoring and re-evaluation process.

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

Create/ Maintain supplier quality agreements.

Support all Procurement supplier Projects.

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

Support all business continuity projects at suppliers.

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

Support internal and external QMS audits, and work as a key player in the audit's backup or inspection rooms.

File and maintain 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.

Collaborate with Quality Engineers, Inspectors, Value Streams, and Purchasing teams.

When required, submit Supplier Corrective Action Requests (SCAR) for Supplier related NCMRs, and review Supplier responses for appropriate root-cause analysis and Corrective Actions to prevent reoccurrence of failure modes.

Support supplier validation activities as required from Supplier Quality prospective.

Support transfer projects and Supplier localization projects.

Support IQ, OQ, PQ and PPAP processes.

Travel: This position may require 10-25% domestic and/or international travel.

Qualifications

Knowledge, Skills and Abilities:

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

Knowledge and experience with a regulated Supplier Management process.

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

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

Previous experience negotiating with Suppliers.

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

Previous experience with Change Control Systems and Design Control.

Excellent verbal and written communication skills and strong organizational skills.

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

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

Work Environment:

Production/Clean Room/Warehouse/Office environment which may require long periods of sitting, standing, or getting up and down throughout the day.

Experience:

3+ years in regulated quality environment.

3+ 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 skillset.

CQE, APICS, Green Belt or Black Belt certifications are a plus.