Full-time, Permanent role 
Location - Waterford 

Force have partnered with the leading global eye healthcare company who are on a lookout for a senior design quality engineer. The Senior Design Quality Engineer is a member of the Global R&D Quality department and plays a key role in ensuring that the Quality System functions are maintained in compliance with documented procedures. 

As Senior Design Quality Engineer, you will work primarily on New Product Development projects, collaborating with all functions on all aspects of our integrated innovation process including – supporting introduction of new products and processes following stage-gate methodology, risk identification & control and serve as the Voice of the Customer during the full end-to-end product innovation cycle - from concept through feasibility, development & commercialization.

Key Duties and Responsibilities: 

• Provide support for development projects from project inception through successful Technology Transfer/Scale-Up at the manufacturing facility.

• The role includes working with global multidisciplinary teams to ensure medical device development and remediation activities are planned and executed in compliance with design control requirements of Bausch + Lomb quality management system, ISO, FDA, and other regulatory agencies.

• Additionally, this role has oversight of the development and maintenance of contact lens device history & risk management files for all assigned products.

• The role will support marketed product changes and updates (MOB).

• The role will also support R&D plant activities along with development laboratory from a quality management perspective

Requirements 

• Minimum 5+ years in medical device or pharmaceutical industry in Quality, R&D, Engineering or Laboratory environment. Specific experience desired as follows:

• Risk management experience.

• Familiarity with relevant regulations and standards (i.e. ISO-13485, ISO-14971, FDA 21 CFR, EU MDD/MDR)

• Quality experience in medical device or pharma industry

• Knowledge of structured problem solving, six sigma, and lean tools