FGO OEMCM Quality Engineer
FGO OEMCM Quality Engineer
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Job Description
What you will do:
.Ownership for OEM/CM quality performance and measurement including KPIs and participate in supplier performance reviews.
Provide support to Internal/ External Customer groups on compliance issues related to assigned OEM/CMs.
Support External Audits and Internal Audits as needed. Ensure Regulatory compliance in area of responsibility to GMP of all medical devices 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 nonconforming 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 and closure
Participate in cross functional projects
Support the developments and approval quality assurance agreements with OEM/CM suppliers
What you need:
Bachelors degree in engineering or science fields or equivalent.
Minimum of 2 years experience in Manufacturing environment.
Knowledge in statistics
Understanding of manufacturing processes
Fluent English.
Preferred Qualifications:
Knowledge with GMP ISOCFR Part 820 standards.
Knowledge of FMEA Validation Programs and SPC processes in a highly regulated environment desirable.
Good knowledge of continuous improvement methodologies.
Employment Type
Full-Time
