Job Category: EngineeringJob Description: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. CooperSurgical is at the forefront of delivering innovative assisted reproductive technology and genomic solutions that enhance the work of ART professionals to the benefit of families. We currently offer over 600 clinically relevant medical devices to women's healthcare providers, including testing and treatment options.CooperSurgical is a wholly-owned subsidiary of CooperCompanies (Nasdaq: COO). CooperSurgical, headquartered in Trumbull, CT, produces and markets a wide array of products and services for use by women's health care clinicians. More information can be found at .Responsibilities:Job Summary:
Lead SCAR, SCN and Supplier Nonconformance processes
Supplier Development activities
Risk Assessments
Essential Functions & Accountabilities:
Manage Supplier Quality sustaining activities.
Other possible activities are listed below.
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).
Supports development and implementation of supplier quality program by doing the following:
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.
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
Supports internal and external QMS audits. And works as a key player in the audit's backup rooms or inspection rooms.
Files and maintains 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.
Collaborates with Quality Engineers, Inspectors, Value Streams as well as Purchasing teams.
When required, submits Supplier Corrective Action Requests (SCAR) for Supplier related NCMRs. And reviews Supplier responses for appropriate root cause analysis and Corrective Actions to prevent re-occurrence 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
Performs additional assignments as required by management.
Travel:10% to 25%Qualifications:QualificationsKnowledge, Skills and Abilities: * Experience with a regulated Supplier Management process including Change Control Systems, FDA QSRs, EUMDR and ISO 14971 & 13485.
Excellent verbal and written communication skills and strong organizational skills
Advance level of English speaking and writing.
Computer skills, MS Office, Minitab, and previous experience with ERP and QMS systems.
Work Environment:
On-site.
Experience:
2 to 4 years of experience in Supplier Management processes
Education:
University Bachelor's Degree in Chemical, Electro-Mechanical, Industrial, Bioprocess Engineering or related to Life Science field.
CQE, APICS, Green Belt or Black Belt certifications are a plus.
