Senior quality engineer (medical devices)

Descripción general

Apply knowledge of quality engineering principles and methods to ensure compliance in product and process development, validations and process optimization, line support, acceptance sampling, and continuous improvement. Provide daily direction and guidance to manufacturing processes and personnel. Establish a Receiving Inspection function including writing and implementing procedures, hiring and supervising Inspection technician to support product and receiving inspections. Write, review and/or approve validation protocols and reports (e.g., cleanroom, equipment, test method and product transfer validation protocols) in accordance with applicable Regulations, SOPs and Good Documentation Practices (GDP). Evaluate risk, manage risk assessment activities and create associated documentation.

Requisitos para aplicar

• Must have BS degree in Engineering or equivalent
• 5 years of experience in quality sustaining within medical device or pharma industry, or related experience required.
• Basic understanding of statistical techniques.
• Manufacturing Engineering and/or Process Validation background preferred
• Proven expertise in usage of MS Office Suite including MS Project; CAD experience preferred
• Advanced English