CooperSurgical is looking to manage and improve supplier quality sustaining activities, ensuring compliance with various regulatory standards and supporting new product development and business continuity projects.
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.
- Understanding, knowledge and application of relevant processes and the various cost drivers per market, commodity or segment.
- Previous experience with Change Control Systems and Design Control.
Responsibilities
- 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).
- Support 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.
Other
- Excellent verbal and written communication skills and strong organizational skills
- Advance level of English speaking and writing.
- Traveling experience is a plus.
- Passing of background check, which may include verification of prior employment, criminal conviction history, education and driving records.
- Travel: 10% to 25%
