Principal Supplier Quality Control Specialist

Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company 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. Our mission is simple, yet powerful: helping you see better, to live better. 

Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing, and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future. 

Position overview:
The Principal Supplier Quality Engineer – External Manufacturing will work directly with Bausch + Lomb External Manufacturing suppliers (B+L is the Legal Manufacturer) and External Legal Manufacturers (B+L is the distributer), to provide sustaining quality leadership and routine support related to current commercialized product as well as newly developed products and Tech Transfers.  In addition, the position will ensure finished product EM suppliers are compliant to all regulatory (US and International) and B+L requirements.

Key responsibilities:

• Identify and implement effective quality systems at the finished EM supplier sites to support the development, qualification, and on-going manufacturing of EM products to meet or exceed internal and external requirements
• Support External Manufacturing Quality Assurance (EMQA) supplier management team in identifying opportunities for improvements
• Complete Non-conformances and CAPAs including root cause investigations related to EM suppliers within required timelines and per established EMQA procedures and systems
• Proactively investigate, identify, and implement best-in-class Quality practices
• Provide technical mentorship and resolve quality supply chain issues with B+L Surgical EM suppliers
• Ensure Surgical External Legal Manufactures are in compliance with EU MDR 2017/745, ISO13485, 21 CFR820 and established procedures as well as ensuring QMS data base is current for the Surgical External Manufacturers portfolio
• Provide effective technical leadership in supporting quality disciplines, decisions, and practices including but limited to the following:
• Validations (Manufacturing, Packaging, Equipment IOPQs)
• Design Risk Analysis / Mitigation
• PFMEAs
• Gauge R&R

  Specifications

• Master Batch Record / Device Master Record / Device History Record
• Medical Device Design Controls
• Change Management
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues with EM suppliers.
• Conduct technical, system, process, product and for cause audits at EM suppliers
• Directly support Surgical EMQA Team for activities related to Supplier Excellence, Management Review, Product Quality Review, SRM/BRM, Audit Schedule and execution, Supplier Risk Assessment & Mitigation, Complaint Review Board and Critical Action Committee

Qualifications and experience:
Bachelor of Science degree in an engineering or life science discipline or related technical field (microbiology, chemistry, etc.) is required.  A minimum of 10 years related Quality Engineering experience (Medical Device or related industry is required).  Expertise in implementing and maintaining quality systems with emphasis in supplier management controls.  Have a working knowledge of EU MDR 2017/745, 21 CFR Part 820, ISO 13485, ISO 14971, Council Directive 93/42/EEC (Medical Devices Directive) and MDSAP.
 

Experience in the following Quality System elements is required:

•   Compliance Auditing of Suppliers
•   Quality Agreements
•   Supplier Risk Management and Mitigation
•   Supplier Corrective Action (SCAR)
•   Supplier Qualification and Lifecycle Management
•   Travel to supplier sites is required.
•   Ability to work with cross functional teams in a fast paced and dynamic environment.
•   Ability to hold people and functions accountable for resolving product quality issues, identifying root cause, implementing corrective and preventative actions, and performing effective verification activities

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.

As required by New York State's pay transparency bill, Bausch + Lomb provides a good faith minimum and maximum salary range of compensation for roles that can or will be performed, in New York State.  Actual compensation is influenced by a wide array of factors including but not limited to skill set, level of experience, and specific office location.  For New York State, the range of starting annual base pay for this role is $100,000 - $155,000

Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

To learn more please read Bausch+Lomb's Job Offer Fraud Statement.

Our Benefit Programs: https://www.bausch.com/careers/benefits/

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

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