Quality Assurance Specialist

2 weeks ago

Kirkwood, Missouri, United States Bausch + Lomb Full time
Company Overview:
Bausch + Lomb is a premier global organization focused on eye health, committed to enhancing and safeguarding vision for individuals throughout their lives. Our mission revolves around improving sight to enhance quality of life. With a diverse portfolio of over 400 products, we cater to a wide range of eye health requirements, supported by a dedicated workforce of approximately 13,000 employees across nearly 100 countries.

Role Objectives:
  • Oversee Product Quality Assurance and Quality Engineering within the Equipment department.
  • Ensure compliance with federal, state, local, and international regulations while maintaining effective quality systems aligned with internal policies.
  • Report quality system performance to site management.
  • Coordinate and manage product nonconformance processes and reports.
  • Support product/process modifications and new product introductions.
  • Lead and/or assist in Corrective and Preventive Actions (CAPA) related to specific responsibilities.
  • Evaluate the effectiveness of quality enhancements and validation activities as part of CAPA requirements.
  • Manage quality assurance tasks associated with material processing, final product inspection, testing, and release.
  • May supervise quality control functions including receiving, in-process inspection, final product release, calibration programs, and complaint evaluations.
  • Possess knowledge and experience in 21CFR820, ISO 13485, MDR, MDSAP, and IEC60601 standards.
  • Demonstrate expertise in design control and verification & validation for systems, software, components, and critical fabrication processes.
  • Experience in Design for Six Sigma (DFSS) particularly in managing critical parameters and process capability.
  • Engage with stakeholders across R&D, Medical Affairs, and Commercial teams to ensure comprehensive understanding of product performance.
  • Translate business objectives into quality strategies and justify quality systems in terms of business efficiency.
  • Exhibit strong interpersonal skills to effectively communicate and influence outcomes.
  • Demonstrate leadership by fostering team collaboration and competency development.
Key Responsibilities:

CAPA Management:
  • Conduct quality data analysis and coordinate initiatives for product and process enhancements.
Quality Systems Development:
  • Create and uphold quality assurance procedures and work instructions for inspection and data analysis.
Process Control Monitoring:
  • Oversee product quality through systematic inspection, testing, and auditing.
  • Ensure compliance with FDA requirements for Device History Records.
Metrics Oversight:
  • Collaborate with operational entities to establish inspection and process control procedures, issuing KPI reports to management.
Product Surveillance:
  • Assist in evaluating and investigating product complaints.
Special Quality Initiatives:
  • Identify and lead quality improvement projects in collaboration with site resources, aligning with operational excellence goals.
Qualifications:
  • Bachelor's degree in Engineering or a related scientific field (or equivalent experience).
  • At least 3 years of experience in Quality Assurance, familiar with ISO 13485 and FDA regulations.
  • Minimum 1 year of experience with CAPA systems in compliance with regulatory standards.
  • Experience in managing nonconforming products and conducting complaint investigations.
  • Utilization of root cause analysis tools and statistical process control.
  • Basic understanding of Lean Manufacturing and Continuous Improvement methodologies.
Preferred Qualifications:
  • Experience in an electro-mechanical assembly manufacturing environment.
  • Specialized training in FDA GMP and statistical analysis techniques.
  • Lean Six Sigma Green Belt certification is desirable.
Benefits:
  • Comprehensive medical, dental, and vision insurance starting on hire date.
  • 401K plan with company matching contributions.
  • Generous paid time off policy including vacation and sick leave.
  • Employee Stock Purchase Plan with matching options.
  • Incentive bonuses and tuition reimbursement for select degrees.
  • Ongoing performance feedback and annual compensation reviews.

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