Supplier Quality Engineer II

CooperCompanies•North Tonawanda, NY

2h•$72,000 - $95,000•Onsite

About The Position

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: North Tonawanda, NY (on-site) Scope: The Supplier Quality Engineer II is responsible for supporting all functions of the Global Supplier Quality Program and the North Tonawanda site-specific functions 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 for pharmaceutical and combination device suppliers.

Requirements

Demonstrated knowledge of pharmaceutical and combination product regulations, including FDA 21 CFR Parts 210, 211, 820 and 4.
Experience supporting suppliers for pharmaceutical, biologic, and/or combination device products in a GMP environment.
Working knowledge of interface requirements between medical device QMS (21 CFR 820 / ISO 13485) and pharmaceutical GMP systems.
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.
3+ years in regulated quality environment supporting pharmaceutical and/or combination device suppliers.
3+ years in working with Supplier Management processes.
Bachelor’s degree in Chemical, Electro-Mechanical, Industrial, Bioprocess/Biochemical Engineering, Materials Science or any related Life Science field or equivalent experience or skillset.

Nice To Haves

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

Responsibilities

Manage Supplier Quality sustaining activities.
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, 21CFR Parts 210 and 211, 21CFR Part 820, ISO 13485, MDD and CMDCAS and other relevant requirements at partner suppliers/vendors to support operations and development engineering. This includes required alignment with FDA pharmaceutical and combination product guidance, including FDA 21 CFR Part 4 (Combination Products), pharmaceutical GMP guidance, and applicable FDA guidance documents governing drug–device combination products.
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.
Ensure supplier quality activities are aligned with FDA pharmaceutical GMP guidelines and combination product regulatory guidance, including appropriate integration of medical device and pharmaceutical quality system requirements.
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.
Perform other duties as assigned.