Senior Design Quality Engineer

Date: Jan 25, 2023

Location: US-NY-Rochester, New York, US

Company: Bausch & Lomb

Bausch+Lomb Companies Inc. (NYSE/TSX: BHC) is a global company that develops, manufactures and markets a range of pharmaceutical, medical device and over-the-counter products, primarily in the therapeutic areas of eye health, gastroenterology and dermatology. We are delivering on our commitments as we build an innovative company dedicated to advancing global health.  Each day, Bausch+Lomb products are used by over 150 million people around the world.

 

Our approximately 21,000 employees are united around our mission of improving people’s lives with our health care products, and we manufacture and market health care products directly or indirectly in approximately 100 countries. 

 

Objective:

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, provide oversight of the development and maintenance of contact lens device history & risk management files for all assigned products.  Ensures that corporate quality management systems are implemented and effectively operating in the R&D laboratory facilities.

 

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
  • 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

 

Qualifications:

  • Bachelors degree in an Engineering or Science discipline
  • 5+ years in a regulated industry, preferred medical device or pharmaceutical industry in Quality, R&D, Engineering roles.  
  • 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

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This position may be available in the following location(s): US - Rochester, NY (GEHC)

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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