**QA Production Engineer (Medical Industry)****Position Summary.
**This position will assist with variety of QA related functions such as: DHR review and product release, Supplier Control, Equipment Asset control, Internal and External Audit Program and other Quality activities.
**Essential Duties and Responsibilities**- Review and compile DHR's for each lot of finished products to verify compliance with good documentation Practices, perform the final Quality release and generate COA.- Responsible for reviewing, approving, and releasing functional reports performed.- Manage database of the released lots and the components used on each lot to ensure traceability.- Reconciliation of released finished product and SCRAP quantities.- Ensure produced quantity of final product is aligned with customer work orders.- Transfer of DHR's using the electronic platform designated by customer.- Assign lot numbers for different manufacturing processes.- Oversee activities of QA production crew.- Assist in the coordination of QA resources for the different manufacturing processes and overtime needs.- Manage Supplier Control program and maintain ASL.- Generate Quality Agreements and Supplier Surveys.- Conduct Supplier Audits and generate reports.- Evaluate Manufacturing Deviations and support resolutions.- Conduct Internal audits and generate audit reports.- Assign, capture, and control equipment and process validation numbers as required by engineering.- Responsible for generating, maintaining, and controlling Asset Numbers, and facility Inventory Numbers.- Participates in activities related with the preparation of external audits.- Act as a SME for QA production processes and Supplier Control during external audits.- Assist in the creation of reports and charts for the Measurement of KPI's related to the quality department.- Be an active enforcer of good manufacturing practices inside and outside the quality department.- Assist in product rework activities, generating forms for the in-process and final release inspections and controls required for quality assurance.- Other duties as assigned**Education and/or Experience.
**- 5 years of experience in Quality Assurance- Bachelor's Degree in life science or equivalent combination of education and relevant work experience.
**Required Knowledge, Skills, and Abilities.
**- English level (advanced)- Working knowledge of QSRs & ISO 13485:2016.- Working knowledge of GMP practices- Strong team player.- Must be well organized, detail-oriented, and able to maintain precise records.- Ability to multi-task, prioritize and manage time effectively.- Must have strong oral and written communication skills.- Familiarity with root cause investigations is preferred