Senior Design Quality Engineer

Date: Sep 15, 2022

Location: IE - Waterford, Ireland - All, IE

Company: Bausch & Lomb

Bausch+Lomb, a division of Bausch Health Companies Inc (BCH), is solely dedicated to protecting and enhancing the gift of sight for millions of people around the world – from the moment of birth through every phase of life. The company is one of the best-known and most respected healthcare brands in the world, offering the widest and finest range of eye health products including contact lenses and lens care products, pharmaceuticals, intraocular lenses and other eye surgery products. 


Our highest priority is the well-being of the people we serve. By listening to our customers and patients, by constantly honing our innovation edge, by executing with integrity and excellence, we strive to earn the trust of our partners and stakeholders.
Over the last 150 years, Bausch + Lomb has become a global hallmark for innovation and quality.  Our talented and motivated colleagues work relentlessly to invent new materials, engineer new technologies, and ultimately bring new innovations to help people see better to live better.

  • 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 require
  • Support R&D development laboratory from a quality management perspective
  • Support internal and external audits as a design quality subject matter expert.  This includes providing front room and/or back room support as required.
  • Support R&D / design quality related NC & CAPA activities
  • Support R&D change control activities

 

Requirements

  • BS or MS in Engineering or Science
  • 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

The masculine is used in this publication without prejudice for the sake of conciseness.
Bausch & Lomb is committed to equal employment opportunity and complies with equal employment opportunity laws in effect wherever it operates.


We are an equal opportunity employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply. Accommodations for job applicants with disabilities are available on reques.

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