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.

　　Objectives:

　　Ensures Quality System is effective, adequate, suitable, and compliant with appropriate global regulatory requirements.

　　Responsibilities:

　　Partner with Operations leadership (Quality, Engineering, Manufacturing, etc.) to ensure compliance to Synergetics Quality Systems, ISO, and regulatory requirements.

　　Responsible for maintaining a compliant and effective Quality Management System: FDA 21CFR Part 820- Medical Device Quality System Regulation, ISO 13485, EU MDR, and other regulatory standards as appropriate.

　　Act as Alternate Management Representative.

　　Manage quality system.

　　Work with management to understand the compliance risks to the business and potential mitigations to those risks

　　Coordinate, lead, and/or participate in, and/or support FDA, governmental, notified body, regulatory, OEM customer, internal, and supplier audits. Develop appropriate reporting/response as needed.

　　Manage internal audit program

　　Ensure proper execution and record retention of quality system documentation and support compliance to quality system requirements.

　　Review and approve quality system documentation as necessary.

　　Track audit nonconformances and drive nonconformances to closure in a timely manner.

　　Manage change control process.

　　Manage (directly or indirectly) document control, training, change management and microbiology functions within Quality Systems group.

　　Participate in CAPA process.

　　Interact routinely with Product Management, Engineering, Production, and Suppliers to proactively improve quality of products.

　　Provide quality and reliability analyses, metrics, and trend reports to Operations and RA/QA management.

　　Generate and approve test protocols, monitor/perform testing, and issue/approve qualification test reports.

　　Participate in design reviews, new product validations, FMEAs and other risk assessment tools as Quality Representative.

　　Provide QS/compliance training to all levels of the organization.

　　Using project management tools and methodologies, lead, facilitate, andcoordinate cross functional teams and projects that assure compliance, and improvement of process, products, customer satisfaction and quality throughout the organization.

　　Ensure utilization of appropriate statistical techniques.

　　Responsible for preparing and hosting Management Reviews.

　　Perform special projects as required by business needs.

　　Must use a collaborative leadership style to successfully achieve objectives.

　　Encourage data driven business decisions by planning and capturing appropriate data and using methodologies for problem solving and analysis.

　　Potentially manage QS responsibilities at multiple facilities.

　　Make presentations on the status of project initiatives to all levels of the organization.

　　Manage and influence those that do not have a direct reporting relationship in order to successfully complete projects and initiatives.

　　Adhere to and ensure the compliance of Synergetics Code of Ethics, all company policies, rules, procedures and housekeeping standards.

　　Develop and implement trend analysis across all device platforms.

　　Ensure the promotion and awareness of regulatory and customer requirements throughout the organization.

　　Other duties as assigned.

　　Requirements:

　　B.S. in Engineering or field of science, or equivalent experience.

　　ASQ CQA, ASQ CBA, ISO Lead Auditor certification, or prior audit experience.

　　Minimum 3 years in quality or engineering role.

　　Experience in a FDA regulated environment.

　　Preferred Qualifications:

　　Experience with Medical DevicesWe offer competitive salary & excellent benefits including:

　　Medical, Dental, Eye Health, Disability and Life Insurance begins on your hire date

　　401K Plan with company match and ongoing company contribution

　　Paid time off – vacation (3 weeks - prorated upon hire), floating holidays and sick time

　　Employee Stock Purchase Plan with company match

　　Employee Incentive Bonus

　　Tuition Reimbursement (select degrees)

　　Ongoing performance feedback and annual compensation review

　　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 (https://hcm2preview.sapsf.eu/bauschhealT4/Bausch_job_posting_statement.docx) .

　　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.