- Support the remediation of Supplier Management CAPA / Quality Plan at CooperMedical, CooperSurgical, and their affiliates.
- Facilitate the supplier compliance program by conducting site audits, driving performance improvements, and supporting supplier development and selection processes.
- Act as a quality assurance consultant to suppliers, assisting them in developing and implementing quality systems that comply with FDA QSR, ISO 13485, EUMDR, CMDCAS, and other relevant requirements.
- Collaborate with Value Streams and Engineering teams to identify supplier-related improvement opportunities and address Non-Conforming Material Reports (NCMRs).
- Develop and implement supplier quality agreements, manage Supplier SCAR / CAPA / NCR processes, and provide metrics/reports for Management Review Processes, Monthly Reports, and Semi-Annual Reports.
- Support new product development initiatives by collaborating with suppliers on validation activities and transfer projects.
- Participate in internal and external QMS audits as a subject matter expert.
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Supplier Quality Assurance Specialist - Alajuela, Costa Rica - CooperCompanies
Descripción
CooperSurgical, a leading provider of fertility and women's healthcare solutions, is seeking a dedicated Supplier Quality Engineer to join our team. We are committed to delivering innovative assisted reproductive technology and genomic solutions that empower healthcare professionals and improve the lives of families.
As a Supplier Quality Engineer, you will play a vital role in ensuring the quality and reliability of our products by collaborating with suppliers throughout their lifecycle. You will be responsible for developing and implementing supplier quality programs, conducting audits, managing corrective actions, and driving continuous improvement initiatives.
Responsibilities:
Qualifications:
The ideal candidate will possess a strong understanding of quality management systems, supplier auditing processes, and regulatory requirements. Excellent communication, interpersonal, and problem-solving skills are essential for success in this role.
