Quality Engineer

Job Description

I have an exciting new opportunity for a Quality Engineer to work with a reputable Medical Device company in Cork on an initial 12 month contract.

In this role, you will be responsible for establishing and ensuring adherence to the validation best practices, while ensuring company and external regulatory, quality and compliance requirements are met.

You will need to have experience and be very familiar with regulatory standards - FDA - Quality System Regulation's, ISO 13485 - and have a proven track record in the execution of Validation Programs in the area of Equipment, Process Information management.

Responsibilities:

• Responsible for supporting the activities in building product Quality into products and assuring compliance to the relevant regulations.
• Work with the various departments in the development and execution of validation activities associated with new equipment upgrades.
• Manages complaint investigation.
• Design and develop validation documentation to support new process/product introductions and process improvement requirements.
• Implementation and coordination of change control processes to promote timely approval of all documentation

Required Education & Experience:

• A Bachelor's degree from an recognised college
• 3+ years experience in a Quality function within the Medical Device / Pharmaceutical industry.
• Have a proven track record in development & execution of validation programs in the area of Equipment / Process Information management
• Familiar with the relevant regulatory standards (F.D.A. - Quality System regulations, ISO 13485) that is applicable to the manufacture of Class III medical devices to Global markets.

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.