Quality Engineer – 6‑Month Contract

About the role

The Quality Engineer will apply Lean, Six Sigma, and advanced problem‑solving techniques to improve systems and processes for CooperVision's medical device distribution and packaging operations. This 6‑month contract position supports the company’s quality strategy, audits, and regulatory compliance.

Key responsibilities

• Develop sampling plans, quality plans, and conduct FMEA and reliability engineering activities.
• Investigate non‑conformances, determine root cause, and implement corrective and preventive actions.
• Perform process and product validations, support internal and external audits, and maintain quality documentation.
• Analyze data using DOE, SPC, ANOVA, Pareto and provide statistical support for improvement projects.

Required profile

• Minimum 3 years of experience in medical device distribution, packaging, or related quality engineering roles.
• Project management, problem‑solving, and strong communication skills.
• Knowledge of 21 CFR Part 820, ISO 13485, and quality system regulations.

Required skills

• Lean, Six Sigma (Green Belt/Black Belt preferred) and DOE methodology.
• Statistical tools: Minitab, Excel, SPC, ANOVA.
• Software: Microsoft Windows, Microsoft Excel, BAAN, Agile, JDA.