External Manufacturing Quality Specialist

Date: Sep 23, 2022

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

Company: Bausch & Lomb

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 nearly 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 12,500 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 summary: 

The Senior External Manufacturing Quality Specialist will support compliant execution of quality-related activities, including but not limited to, Non-conformance, CAPA, change management, documentation management, problem solving, product and process development, product acceptance activities and training.  This position will also work directly with Bausch Health Finished Good (FG)/External Manufacturing (EM) suppliers, as well as medical device product manufacturing facilities, to provide sustaining quality and compliance leadership and routine support related to current commercialized products.

 

Key responsibilities:

  • The scope of this position is directly related to the Surgical External Manufacturing.
  • Identify and implement effective quality control systems at the Medical Device EM supplier sites to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
  • Collaborate and support or lead companywide quality planning continuous improvement projects (e.g. QSIP etc.)
  • Ensure Finished Good/External Manufacturing suppliers are compliant to all regulatory (US and International) and Bausch Health requirements.
  • Support Supplier Management team in identifying opportunities for improvements.
  • Complete Non-conformances and CAPAs related to FG EM suppliers within required timelines.

 

  • Proactively investigate, identify and implement best-in-class Supplier Quality practices.
  • Provide technical mentorship and resolve quality supply chain issues with Bausch Health and FG EM suppliers.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues with FG EM suppliers.
  • Assist EM QA functions, supply chain and R&D organizations in sourcing and qualifying new FG EM suppliers.
  • Participate in quality change request management activities, corrective and preventive actions as well as effectiveness verification activities, as required.
  • Assist quality management in all audits (FDA, Notified Body, other Regulatory agencies).
  • Directly support management team for activities related to Annual Product Reviews, Management Review, Complaint Review Board and Critical Action Committee.

 

Qualifications/experience:

  • Bachelor of Science degree in an engineering discipline (Mechanical, Biomedics, materials, Industrial, etc) or related technical field (microbiology, chemistry, etc) is required.
  • A minimum of 6 years within a supplier quality, manufacturing or packaging organization (minimum 4 years in the Medical Device or Pharmaceutical industry) is required.  A Master’s degree in an engineering or technical related discipline may be substituted for two years of experience.
  • ASQ Certification preferred but not required (such as CQA, CQE, CMQ/QE)
  • Excellent communication and customer service skills (verbal and written).
  • Ability to successfully influence others within project teams regarding quality or compliance concerns.
  • Excellent organizational and presentation skills.
  • Audit experience preferred.
  • 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.
  • Demonstrated expertise in Implementing and maintaining quality systems with emphasis in Supplier management controls.
  • Familiarity with 21 CFR Part, 820, ISO 13485, MDSAP, EU MDR 2017/745.
  • Ability to travel to supplier sites is required.
  • Proven track record of successfully working with cross functional teams in a fast paced and dynamic environment handling a variety of requests from many stakeholders.

  

 

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.

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.