Job Summary

• The role involves leading quality improvement efforts for legacy products and continuous improvement initiatives to ensure customer satisfaction.
• Candidates will be responsible for developing risk management plans, writing validation protocols, and utilizing statistical tools like Six Sigma and DOE.
• The position requires supporting vendor audits, investigating corrective actions, and assisting Regulatory Affairs with process change submissions.

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Skills & Requirements

Key Requirements

• Bachelor's degree required
• 4-6 years experience in medical device industry
• Thorough knowledge of GMP and QSR
• Experience with design control and V&V tools
• Auditing and problem-solving skills

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