FGO OEM/CM Quality Engineer

What you will do:

•Ownership for OEM/CM quality performance and measurement including KPI’s and participate in supplier performance reviews.
•Provide support to Internal/ External Customer groups on compliance issues related to assigned OEM/CM’s.
•Support External Audits and Internal Audits as needed. Ensure Regulatory compliance in area of responsibility to GMP of all medical device’s regulatory agencies (i.e. FDA, IMB, Notified bodies, etc)
•Participate in the OEM/CM material related processes which include: Material Review Board to ensure Coordination of MRB activities with the business unit to ensure the timely assessment of potential non-conforming products.
•Maintain structured communication channels with strategic sourcing, identifying responsibility by OEM/CM.
•Liaising with the Manufacturing and Quality groups, in assessing and addressing material quality issues with assigned OEM/CM.
•Maintenance of the Approved Supplier List (ASL) in conjunction with the Global Sourcing, Supplier Controls and Audit functions
•Support continuous improvement activities focusing on OEM/CM quality
•Work on assigned NPI/Site Integration/Product Transfer & M&A projects and ensure compliance of FGO QMS requirements.
•Support the assessment of OEM/CM new supplier addition/changes to existing suppliers for NPI/Site Integration/Product Transfer & M&A projects
•Support the divisions in completion of Part Certification/OEM checklists for new projects assigned
•Responsible for conducting due diligence of new Suppliers and support Supplier controls in onboarding these Suppliers through addition to ASL
•Participate in supplier audit program – planning, execution and closure
•Participate in cross functional projects
•Support the developments and approval quality assurance agreements with OEM/CM suppliers

What you need:

Bachelor’s degree in engineering or science fields or equivalent.
Minimum of 5 years’ experience in Manufacturing environment.

Fluent in written & oral English..
Basic knowledge with GMP, ISO 13485, 21 CFR Part 820 standards.
Basic knowledge of FMEA, Validation Programs and SPC processes in a highly regulated environment desirable.

Good knowledge of continuous improvement methodologies.