Medical Device Quality Engineer - Lean Six Sigma

Regulatory Jobs; Town of Henrietta (NY); On-site; USD 70,000 - 93,000; Full time

Job summary

CooperVision, a division of CooperCompanies, is a leading global manufacturer of soft contact lenses. This Quality Engineering role uses Lean, Six Sigma, and root cause analysis to optimize systems and processes aligned with company strategy and quality systems.

You will develop quality plans, conduct audits, support risk management, and lead improvement projects across distribution and packaging operations, ensuring compliance with internal specs and regulatory requirements.

Qualifications

• Bachelor's degree in engineering or related discipline; equivalent combination of education and experience may be considered.
• Certified Quality Engineer, Green Belt or Lean certified preferred.

Responsibilities

• Utilizes quality engineering and lean tools to establish sampling plans and quality plans; conducts FMEA and supports reliability engineering.
• Investigates nonconformances and facilitates root cause and corrective action/preventive actions including effectiveness.
• Analyzes routine and test data for improvement opportunities; designs experiments (DOE) for process and product improvement and validation testing; develops validation plans.
• Supports, consults, trains and leads quality improvement projects.
• Provides statistical support for sampling plans and analysis (DOE, Pareto, ANOVA, SPC).
• Gathers and evaluates distribution center and packaging performance; develops criteria to monitor and improve processes via quality KPIs.
• Develops personal and departmental performance objectives based on facility quality objectives; reports monthly on progress.
• Supports internal and external audits as needed.
• Oversees and participates in process and product validations to ensure compliance with specs, ISO, and regulatory requirements.
• Reviews, develops and maintains documentation including risk management files and quality records.
• Partners with Quality Assurance to provide oversight of Quality Systems and processes; delivers workshops and training as required.
• Provides process mapping and modeling; offers guidance and options.

Job description

CooperVision, a division of CooperCompanies, is a leading global manufacturer of soft contact lenses. This Quality Engineering role uses Lean, Six Sigma, and root cause analysis to optimize systems and processes aligned with company strategy and quality systems.

You will develop quality plans, conduct audits, support risk management, and lead improvement projects across distribution and packaging operations, ensuring compliance with internal specs and regulatory requirements.