Senior Design Quality Engineer

Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc., is solely focused on making people see better to live better. The company has a 40-year track record of growth and diversification in Waterford – Ireland’s oldest city. 

From Waterford, Bausch + Lomb supplies eye health products to people across the world.

The company’s success in Waterford has been built on a great team who between them have thousands of years of experience of delivering the highest quality every time. As the facility has grown, new opportunities have been created for skilled people to join the team and take their careers to the next level in a global company with deep local roots in Waterford.

This position involves the following;

Provide full contact lens product life cycle design quality support from product inception through sunsetting.  This includes ensuring that product development projects are executed in compliance with the 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.  This role also has responsibility to ensure that corporate quality management systems are implemented and effectively operating in the R&D laboratory facilities.

Key Duties & Responsibilities

• Represent design quality on new contact lens product development and/or device maintenance of business teams.  Duties will include:
  • Ensure project plans comply with B&L, FDA, other regulatory agency, and ISO design control requirements.
  • Ensure projects adequately meet design, development, technology transfer, validation, and post launch requirements in accordance with the corporate product development process (PDP).
  • Drive and apply Advanced Quality Planning principles for new product/manufacturing process development activities to ensure effective, efficient and complaint transfer to manufacturing operations.
  • Manage the documentation of product design control activities (i.e., DHF, DHFI, etc.)
  • Manage product risk management requirements per ISO 14971.
  • Review and approve R&D equipment qualification protocols, product/process specifications, analytical method qualifications, development engineering protocols, validation strategies/protocols/reports, clinical trial material protocols & batch records, etc.
  • Issue QA Product Release authorizations for new products
• Complete and provide risk management and/or complaint data updates to annual Product Quality Reviews (PQR), revisions to Design Risk Analysis, and input to Clinical Evaluation Reports.
• Support post launch design changes as required

Requirements

• BS or MS in Engineering or Science is desirable
• 5+ years in medical device or pharmaceutical industry in Quality, R&D, Engineering roles.  Specific experience desired as follows:
• 5 years in medical device product development
• Experience in Advanced Product Quality Planning (APQP)
• Familiarity with relevant regulations and standards (i.e., FDA 21 CFR, EU MDD/MDR, ISO-13485, ISO-14971)
• Risk Management
• Complaint Management
• Process Validation
• Knowledge of structured problem solving, six sigma, and lean tools
• Self-Motivated with ability to handle multiple priorities
• Decisive, good communicator
• Ability to influence strategic decisions

Bausch & Lomb is committed to equal employment opportunity and complies with equal employment opportunity laws in effect wherever it operates.