Supplier Quality Engineer

hace 6 meses

Alajuela, Costa Rica CooperCompanies A tiempo completo

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 .

Support any required remediation of Supplier Management CAPA / Quality Plan at CooperMedical, CooperSurgical and their affiliates. Other possible activities are those 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, EUMDR, CMDCAS and other relevant requirements at partner suppliers/vendors 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: a. Support supplier on-going monitoring and re-evaluation process.  b. Manage Supplier SCAR /CAPA/ NCR and periodically provide metrics/report to Management Review Process, Monthly Reports, and Semi-Annual Reports. c. Create/ Maintain supplier quality agreements. d. Support all Procurement supplier Projects. e. Support all new Product Development that is intended for production at suppliers. f. Support all business continuity projects at suppliers. g. 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 front room, 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 perspective.  Support transfer projects and Supplier localization projects. Support and lead IQ, OQ, PQ and PPAP processes. Performs additional assignments as required by management.

Knowledge, Skills and Abilities:

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. Excellent verbal and written communication skills and strong organizational skills University bachelor’s degree in Chemical, Electro-Mechanical, Industrial, Bioprocess Engineering or related to Life Science field or equivalent experience or skill sets. CQE, APICS, Green Belt or Black Belt certifications are a plus. 5 or more years of related experience in a regulated quality environment. Advance level of English speaking and writing. Traveling experience is a plus. With previous experience negotiating with Suppliers. Computer skills, MS Office, Minitab, and previous experience with ERP and QMS systems. Passing of background check, which may include verification of prior employment, criminal conviction history, education and driving records. Understanding, knowledge and application of relevant processes and the various cost drivers per market, commodity or segment.  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 Advance level of English speaking and writing. Traveling experience is a plus. Computer skills, MS Office, Minitab, and previous experience with ERP and QMS systems. Passing of background check, which may include verification of prior employment, criminal conviction history, education and driving records.

Experience:

5 to 7 years in regulated quality environment. 3 to 7 years in working with Supplier Management processes

Education:

Bachelor’s degree / Master’s degree Black Belt a plus Certified Quality Engineer, Certified Reliability Engineer a plus

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