Provide effective and responsive QA support to Operations to resolve in-house, customer and supplier issues.
•Ensure Regulatory compliance in area of responsibility to GMP of all medical devices regulatory agencies (i.e. FDA, IMB and BSI).
•Assist in development, review and approval of process and equipment validation (IQ, OQ and PQ).
•Ensure compliance of QMS procedures within the Business Unit.
•Lead Problem Solving meetings using the following: 4D, Six Sigma, etc.
•Lead pFMEA/Dynamic Control Plan (DCP) activity and ensure that all failure modes in process have been identified and addressed.
•Drive and implement plant wide quality system improvements.
•Participate in the development and improvement of the manufacturing processes for existing and new products. Coordination of PPAP activities.
•Provide functional expertise to other support function on quality related issues.
•Manage NCR Process.
•Interface with Suppliers for new processes, quality Issues and Process Improvements.
•Work cross functionally with such groups as Regulatory, Product Development and Operations to ensure all issues are successfully resolved.
•Lead training activities on Quality related Procedures, e.g. Compliance, GMP, Audit Prep and GDP.
•Support Manufacturing Cell in addressing Quality Metrics, e.g. CAPA, sCAPA, Validations, Process Changes, NCR, Quality Alert, Quality Challenge.
•Complete Manufacturing Cell Audits, Internal Audits Supplier Audits, as required.
•Support site during External Audits. (i.e. FDA, IMB and BSI).
•Support/ act as local subject expert for review, creation and training of divisional/corporate procedures.
•Responsible for input to Quality Metrics.
•Evaluation of Customer Complaints (PER Investigation) as required.
Skills and Education