Senior Quality Lead driving non-conformance reduction and process validation in FDA regulated environments. Collaborating to oversee global quality and regulatory requirements for medical device manufacturing.
Responsibilities
Act as Subject Matter Expert (SME) for non-conformance
Drive non-conformance reduction and process validation maturity
Implement and provide oversight of global Quality and Regulatory requirements
Oversee the Quality Assurance activities in manufacturing processes
Have an impact on introduction/validation of new/changed manufacturing processes
Serve as best practice/quality resource within your discipline
Requirements
7+ years’ experience in quality engineering within FDA regulated medical device manufacturing environments
strong knowledge of principles, theories, and concepts relevant to Quality Engineering (CQE body of knowledge)
detailed knowledge of appropriate global medical device regulations, requirements and standards
strong knowledge of Risk Management (ISO 14971, FMEA)
Acceptance activities, Non-Conformance, Production and Process Controls, and Process Validation activities
Minimum of a Bachelor’s Degree in Quality, Engineering or related field
Lean Six Sigma Black Belt or Master Black Belt certified
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