Quality Engineer- Medical Device

ICDS Recruitment

Clare

Quality Engineer- medical device: County Clare. Job Summary. Act as a key contributor to the effective collaboration between the product engineering, manufacturing and quality functions; providing specialist expertise in the areas of Quality Assurance, Regulatory Compliance, Design Controls and Risk Management (particularly around technology transfer. Duties & Responsibilities include but are not limited to: • Understand the requirements of Design Control and facilitate design review meetings. • Provide Quality/Engineering support with a focus on Process validation to the design and transfer into manufacturing team. • Preparing/Reviewing Master Validation Plans, Design specifications, and risk management documentation. • Work within project teams to establish process controls that ensure the product is manufactured in a compliant manner. • Providing ongoing communication and documentation to the design and technology transfer teams to ensure compliance with design control documentation. • Ongoing monitoring of the company's quality objectives and performance metrics. • Collaborate with the operations function to help facilitate the successful execution of the new product/project development project. • Work closely with Quality Management, assisting in continuous development of the QMS. • Engage early in the product development cycle with Validation Engineers. Education & Experience Required: • Degree in Quality, Engineering or equivalent. • At least 5 years in Quality/GMP environment in the Medical Device industry. • Good knowledge of Design Control and validation required. • High level of interpersonal, communication and organisational skills required. • Ability to take initiative, influence cross-culturally and functionally, organise and prioritise own work and to actively contribute to project level planning. This job originally appeared on RecruitIreland.com.

2040 days ago