More jobs:
Supplier Quality Specialist II
Job in
Kirkwood, St. Louis County, Missouri, USA
Listed on 2026-06-25
Listing for:
DBA-Verwaltungs-Gmbh
Full Time
position Listed on 2026-06-25
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist, Quality Control - QC Analysts/Managers, QA Specialist - Analyst/Manager -
Engineering
Quality Engineering, Regulatory Compliance Specialist, QA Specialist - Analyst/Manager
Job Description & How to Apply Below
Bausch + Lomb is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world.
ObjectiveLead 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.
SupplierQuality 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.
- Support Purchasing and Operations in supplier evaluation, selection, and approval activities.
- Lead and perform supplier audits, on‑site 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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…
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