CooperSurgical is seeking to ensure that all suppliers consistently meet quality standards and regulatory requirements for their Global Supplier Quality Program.
Requirements
- 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.
- Computer skills, MS Office, Minitab, and previous experience with ERP and QMS systems.
- Previous experience in supply chain, auditing, verification, and validation, GD&T.
- Previous experience with Change Control Systems and Design Control.
Responsibilities
- Lead SCAR, SCN and Supplier Nonconformance processes
- Supplier Development activities
- Risk Assessments
- Manage Supplier Quality sustaining activities.
- 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).
Other
- Work location: Trumbull, CT (on-site)
- 10% to 25% Travel
- Excellent verbal and written communication skills and strong organizational skills
- Advance level of English speaking and writing.
- Passing of background check, which may include verification of prior employment, criminal conviction history, education and driving records.
