QA Production Engineer

hace 3 semanas

Tijuana, México North American Production Sharing A tiempo completo

**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

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