Senior Supplier Quality Specialist - Medical Devices

Objective Lead and execute Supplier Quality Assurance activities for both new and existing suppliers supporting the Surgical Equipment business unit. This role ensures supplier compliance and product quality across new product development (NPD), maintenance of business (MOB), and cost improvement projects (CIP). The position partners closely with cross‑functional teams to support sourcing decisions, supplier qualification, process validation, and effective resolution of supplier quality issues to ensure regulatory compliance, supply continuity, and continuous improvement. Responsibilities Supplier Quality Leadership & Collaboration Represent Supplier Quality in internal project meetings, manufacturing readiness reviews, and cross‑functional forums, leading supplier‑related quality deliverables. Act as the primary Supplier Quality liaison between Manufacturing, Manufacturing Engineering, Purchasing, Operations Quality, Regulatory Affairs, Global Quality, R&D, and suppliers. Supplier Evaluation, Qualification & Audits Support Purchasing and Operations in supplier evaluation, selection, and approval activities. Lead and perform supplier audits, onsite assessments, and risk evaluations for new and existing suppliers to ensure compliance with ISO standards, regulatory requirements, product specifications, and corporate/local quality requirements. Maintain supplier qualification documentation, including quality agreements, certifications, and risk assessments. Product & Process Qualification Coordinate and execute supplier part and process qualification activities, including First Article Inspection (FAI), receiving inspection planning, process capability studies, PFMEAs, Control Plans, and process validation. Ensure supplier processes meet Bausch + Lomb general and product‑specific requirements for services, components, and finished goods. Change Management & Issue Resolution Review, approve, and manage supplier‑initiated change notices and documentation for product revisions, line extensions, and service changes. Lead investigation and resolution of supplier‑related quality issues, including nonconforming materials, internal failures, customer complaints, and audit findings. Manage root cause analysis, corrective and preventive actions (CAPA), implementation, and effectiveness verification. Performance Monitoring & Continuous Improvement Establish, monitor, and report supplier quality performance metrics (e.g., OTD, quality performance, responsiveness). Drive supplier performance improvement initiatives in partnership with Quality and Operations. Support cost of quality reduction initiatives and supplier risk mitigation strategies. Quality Systems & Compliance Develop, implement, and maintain site‑level supplier quality procedures to ensure alignment with regulatory, corporate, and local requirements. Review and provide input on new or revised corporate procedures impacting supplier quality or site operations. Author, review, and implement policies and procedures to strengthen supplier quality processes and enable continuous improvement. Qualifications Education Bachelor's degree in Engineering, Biology, or a related technical discipline, or equivalent experience required. Preference given to candidates with engineering or other technical degrees. Required Experience Minimum of 5 years of Quality experience in the medical device industry or other regulated industries (e.g., aerospace, automotive). At least 3 years of experience in supplier quality‑related roles or processes. Proven track record of successfully managing supplier quality issues, projects, and cross‑functional initiatives in a regulated environment. Experience developing and implementing quality processes across global supplier manufacturing sites. Required Skills & Competencies Strong verbal and written communication skills. Ability to manage multiple priorities with minimal supervision. Demonstrated organizational, analytical, and problem‑solving skills. Effective supplier relationship management and follow‑through. Proficiency in Microsoft Office applications. Preferred Experience & Certifications Medical device supplier auditing experience. Professional certifications such as ASQ CQE, CQA, CQM. Six Sigma Green Belt, Black Belt, or Master Black Belt certification. 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. U.S. based employees may be eligible for short‑term and/or long‑term incentives. They may also be eligible to participate in medical, dental, vision insurance, disability and life insurance, a 401(k) plan and company match, a tuition reimbursement program (select degrees), company holidays, and well‑being benefits, among others. U.S. based employees are also eligible to receive sick time, floating holidays and paid vacation. 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: Employee Benefits: Bausch + Lomb ( 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. #J-18808-Ljbffr Bausch + Lomb