Director, Quality

Date: Aug 6, 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:

This executive position will establish the Bausch + Lomb Design for Quality Process across the full product life cycle management process that includes Design for Six Sigma, and Lean Sigma for sustained, right first time product and process development, realization, and life cycle management.

 

Key responsibilities:

Establishes and oversees the Bausch + Lomb Design for Quality and Product Life Cycle Management Processes

Establish Systems and Processes that guide RFT Product and Process Development, technical transfer, and lifecycle management across the full value chain

Establishing and communicating strategic goals and objectives in alignment with Business Unit and site objectives for these programs

Lead and promote an organizational culture of continuous quality improvement and operational excellence for efficient resource use and management of total cost of quality

Provide cross-functional leadership to Medical Device BU Stakeholders on programs that enhance the DFQ / PLM programs

Ensure DFQ Processes, including Design for Six Sigma that ensure safe, effective, and compliant products are developed, produced, and delivered to our customers, on time and in full

Ensure processes are in place for Design Control, including Risk Management, Requirements Management (Input, Output, Verification) that are compliant with applicable standards and which ensure products are released in compliance with all applicable standards

Ensures inspection readiness with respect to design control, change control, and product life cycle management.

Enable DFSS talent to deliver Product and Process excellence

Promote a prevention focused, committed, and aligned learning organization and total quality culture

 

Qualifications/experience:

BS degree required in biomedical engineering, material science, or similar science degree; advanced degree is preferred.

Requires a minimum of 10 years of experience in the medical device, or similar device (plastics, mechanical, electronics and/or software), including holding recent senior level positions in quality, operations, and/or research and development.

ncumbent must have strong business acumen and leadership influencing skills.

Incumbent must have knowledge of Design for Six Sigma, Design Control, Change Control, and Product Life Cycle (Stage Gate) management processes.  Similar processes such as Quality by Design will be considered.

Must possess in-depth knowledge of current medical device regulations and regulatory agency organizations.  In addition, a strong understanding of inspection techniques, including quality, engineering principles and statistical methodology is required.  Because of the organization size and diversified product line and technical structure of the organization, the incumbent must possess good interpersonal ability to work with general managers, commercial and operations leaders across the respective business units.

 

 

  

 

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.