Manager, Quality Assurance

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. 

Overview:

Exciting opening, in support of our Specialty Vision Products division, based out of Wilmington, MA.  The Bausch + Lomb Specialty Vision Products groups are dedicated to delivering innovative products, education, and training for eye care professionals in the customized contact lens category. 

Great opportunity for someone who enjoys working within a smaller manufacturing operation and likes to have an immediate and significant impact to the Quality program. 

Responsibilities:

• Ensures that a Quality Management System for Specialty Vision Products business is implemented, maintained, and effective for product manufacturing, control, storage, and primary distribution processes in accordance with Bausch Health Quality Manual, Quality System Directives, all applicable Quality Systems standards and regulations (i.e. FDA QSR, ISO 13485:2012, MDD, and Canadian SOR etc.)
• Responsibilities include, but are not limited to: validations, NC/CAPA system, GMP documentation, complaint investigations, design control, risk management and change control, supplier quality management, implementation of regional quality systems and requirements, GMP and ISO quality system training, preparation of management and product quality reviews.
• Includes establishing business/site specific Quality Plans, objectives, appropriate quality metrics and management updates.
• Includes the preparation and maintenance of Quality budgets and the training/growth/development of Quality personnel.

Scope of position:

• Full responsibility for Quality function for assigned site(s) including overall responsibility for the Quality Management System and State of Compliance.
• Ensurins compliance with Bausch Health Quality Manual and Quality System requirements.
• Implementation and management of an effective, efficient and compliant (E²C) Quality Management System for the Specialty Vision Products operations.
• Establishment and ongoing development of an effective Quality team to support the growth of the Specialty Vision Products business.
• Collaborate with Operations to identify and implement continual improvement initiatives to drive the long-term success and profitability of the Specialty Vision Products business.

Qualifications:

• Bachelor’s Degree BS in engineering or scientific discipline (Chemistry, Biology, Microbiology or related technical field).
• 10+ years of experience in Quality assurance, Quality systems, or Quality management in the medical device industry. Proven track record of accomplishment in leading an operation/business in the development, implementation and management of a successful Quality Management Strategy and program.
• Must possess a deep understanding of applicable Quality System requirements/regulations and how they are applied in an efficient, compliant manner.
• 5+ years Quality Assurance experience in a high-volume manufacturing facility, including successful interactions with regulatory agencies. Six Sigma GB, BB, or MBB preferred.
• 5+ years in management, with a proven track record of successful people management and development of personnel

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This position may be available in the following location(s): US - Wilmington, MA

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.

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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