Quality Engineer - EUMDR Projects - Medical Devices

We are seeking a Quality Engineer to work on a team at our client site in Mahwah, NJ.

Provide quality engineering support in quality assurance, Advocate and lead the execution of initiatives & EUMDR project. Ensure compliance to regulation and standards.

Having knowledge of and ability to provide Interpretation and Guidance on Regulations, Corporate, Divisional and Site Local procedures as they relate to validation activities. Discuss / give feedback in validations. Support executing, reviewing and approving Validation/Qualification Documentation. Working with Validation team and Consultants/Contractors as required ensuring that Validations are completed per corporate and divisional procedures.

Comments

Will work within the quality operations team, with moderate supervision and mentoring, with responsibility for quality related activities, including, but not limited to the following:

• Work closely with operations and the business functions to ensure quality performance of product and processes.

• Participate in the development and improvement of the manufacturing processes for existing and new products.

• Review of change management activities.

• Develop understanding of risk management practices and concepts, ability to become proficiency in process risk.

• Assist in the development and review of process and equipment validation/qualification. Build proficiency in validation processes.