Senior Supplier Quality Specialist

Date: Aug 6, 2022

Location: US-MO-Fallon, Missouri, 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. 

 

OBJECTIVES/
PURPOSE OF JOB

Responsible for Supplier Quality Assurance of new and existing product designs and product line extensions led by B+L or designated organization (e.g., R&D) at the surgical business unit including, but not limited to: product sourcing decision support; advanced product quality planning; suppliers assessment and qualification; validation of supplier processes; qualification of components, finished products and/or services; and concern resolution processes.

 

Additionally, it may function in the same capacity to support maintenance of business (MOB) projects and cost improvement (CIP) projects, etc.

 

KEY ACTIVITIES/
RESPONSIBILITIES

 

Represent Supplier Quality in internal and external project meetings and manufacturing readiness reviews and leads supplier activities on multiple Quality deliverables during qualification, approval, implementation phases, and lifecycle oversight of suppliers.

 

Acts as the Supplier Quality liaison between Manufacturing, R&D Engineering, Purchasing, Operations Quality, and the supplier.

 

Supports purchasing and R&D with source identification, evaluation, and selection. Leads On-Site Assessments and evaluation of supplier questionnaires, risk assessment and feasibility reviews.

 

Assists R&D and the project team in the definition of critical product characteristics and provides feedback on design manufacturability assessments to ensure a successful design transfer with robust specifications to suppliers.

 

Coordinates supplier quality activities necessary to fulfill B+L general and specific requirements for product qualification such as First Article Inspection, receiving inspection processes, supplier process controls, capability studies for critical product characteristics and implementation of PFMEAs and control plans, process validation, among others.

 

Develop and maintain local supplier management procedures to ensure that regulatory, local, and corporate (Global) requirements are met. Review and provide input to new/revised corporate procedures that impact the site.

 

Manage audit schedule.  Perform supplier audits for new suppliers to assure products/services meet the requirements of applicable ISO standards, regulations, product specifications and B+L local and corporate requirements. Perform surveillance audits of existing supply base as needed per established procedure.

 

Lead/participate in Material Review Board.

 

Responsibilities may include up to 25% travel

 

Reviews receiving inspection results and verify first receipt is accepted.

 

Reviews and processes supplier-related Change Notices and documentation.

 

Ensures resolution of supplier related quality problems, including internal failures, customer complaints and audit findings by managing nonconforming product disposition, supplier investigation of root cause, corrective action planning, implementation, and verification of effectiveness.

 

Establishes, reports, and sustains key supplier quality performance metrics and corresponding training, improvements, and reporting responsibilities.

 

Ensure supplier documentation is maintained including risk assessments, quality agreements, quality system certifications and supplier status management.

 

Supports costs of quality reduction goals and supplier risk mitigation activities.

 

Authoring, reviewing and implementation of policies and procedures, to drive supplier quality improvement processes for continuous improvement.

 

 

SUPERVISE DIRECT REPORTS

(yes or no)

No

SCOPE OF POSITION

 

 

 

 

 

 

 

The scope of the position is primarily focused on supplier quality activities affecting current operations as well as new suppliers.

KEY RELATIONSHIPS

 

 

 

 

 

Internal customers/business partners:

-Potential and current suppliers

-Research and Development

-Purchasing

-Regulatory Affairs

-Operations

-Manufacturing Engineering

-Site and Global Quality

 

QUALIFICATIONS/
TRAINING

 

 

 

Required Education:

BS in Business; Biology, Chemistry, or related field of science; Engineering; or Pharmacy (or equivalent experience)

 

Preference given to degreed engineers or technical degree type.

 

 

Preferred Education:

 

Required Skills/Qualifications:

  • Demonstrated hands on supplier management experience at FDA and ISO Regulated environment.
  • Excellent verbal and written communication skills.  Ability to prioritize multiple tasks and projects with limited direct supervision.  Effective organization and negotiation skills.  Strong ability to manage suppliers, follow-up, and complete projects.  Proficient in MS Office Applications
  • ASQ CQA, ISO Lead Auditor, or prior auditor experience required.

 

Preferred Skills/Qualifications:

 

Required Experience:

5+ years’ Quality experience in the Medical Device Manufacturing industry; 3+ years in supplier quality related processes. Must have proven and results-driven track record of successfully managing projects, people, and suppliers. Responsible for developing & implementing quality processes in a global business environment, including supplier manufacturing sites.

 

Preferred Experience: 

Additional consideration for experience in other highly regulated industries (automotive, aerospace, etc.) and for the following certifications:  ASQ CQE, CQA, CQM and Six Sigma Green Belt, Black Belt, and Master Black Belt.

 

 

 

This position may be available in the following location(s): [[O'Fallon, MO]]

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.