Varification & Validation Engineer - Medical Devices (V&V)

Responsibilities:

• Support all V&V activities, including: process validation, software validation, Sterilization validation, and Annual Validations: sealing machine, packaging, and product bioburden.
• Support all calibration process.
• Support supplier approval process.
• Support QA activities including non-conformity and etc.  
• Assist project teams in product development activities including coordinating planning activities, monitoring the release of documents and phase transition activities including design reviews and verification and validation activities.

Requirements:

• Bachelor's Degree (BA/BS) in Engineering or Life Sciences discipline required.
• Minimum four (4) years V&V Engineer of experience in Medical Devices or other health care regulated industries required (ISO 13485:2016, CFR 820, MDSAP).
• Experience with FDA, Health Canada, EU, Notified Body, and/or international regulators is strongly preferred.
• Ability to clearly communicate and write protocols and reports in English.
• Experience in the design control process.