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Quality Assurance Specialist
2 months ago
Bausch + Lomb is a premier global organization in eye health, committed to enhancing and safeguarding vision for individuals worldwide, from infancy through all life stages. Our mission is straightforward yet impactful: to help you see better, thereby enabling a better quality of life.
About Us:
With a diverse range of over 400 products, we are fully equipped to meet our customers' eye health requirements throughout their lives. Our esteemed brand is built on the trust and loyalty of our customers, cultivated over our 170-year legacy. Our global presence includes approximately 13,000 employees across nearly 100 countries, reaching billions of potential customers. We have been at the forefront of significant advancements in eye health and are poised to continue leading in this vital field.
Key Responsibilities:
- Quality Assurance and Engineering: Oversee product quality assurance and engineering within the Equipment department.
- Regulatory Compliance: Ensure quality systems are effective and adhere to applicable federal, state, local, and international regulations, alongside internal policies.
- Performance Reporting: Provide insights on the quality system's performance to site management.
- Nonconformance Management: Coordinate and manage product nonconformance processes and reports.
- Product Launch Support: Assist in product/process modifications and new product introductions.
- CAPA Management: Own and support Corrective and Preventive Actions related to specific responsibilities.
- Quality Improvement Monitoring: Assess the effectiveness of quality enhancements and validation activities.
- Quality Assurance Activities: Manage quality assurance tasks associated with material processing, final product inspection, testing, and release.
- Supervision: Potentially oversee quality control functions, including inspection and complaint evaluation.
- Bachelor's degree in Engineering or a related scientific discipline (or equivalent experience).
- A minimum of 3 years in Quality Assurance, with experience in ISO 13485 and FDA regulations.
- Experience with CAPA systems and nonconforming product management.
- Proficiency in root cause analysis and problem-solving methodologies.
- Basic understanding of Lean Manufacturing and Continuous Improvement principles.
- Experience in an electro-mechanical assembly manufacturing environment.
- Lean Six Sigma Green Belt Certification is desirable.
- Comprehensive medical, dental, and vision insurance starting on the hire date.
- 401K plan with company matching contributions.
- Generous paid time off policy.
- Employee Stock Purchase Plan with matching.
- Tuition reimbursement for select degrees.