Develop, maintain, and oversee EMI wide quality assurance programs, policies, and procedures.
Harmonize quality management system (QMS) processes across EMI plants to ensure consistency.
Support EMI sites during internal, external, and regulatory audits; conduct site visits and provide audit preparation.
Assist plants in defining and implementing quality system best practices.
Lead manufacturing quality initiatives and drive timely resolution of quality issues.
Manage product realization activities including line transfers and New Product Development (NPD) introductions.
Ensure manufacturing readiness for design & manufacturing transfers.
Support EMI plants with supplier oversight and manage related nonconformance investigations.
Requirements
Bachelor’s degree in Engineering, Quality, Life Sciences, or related field.
Minimum 5 years of experience in Quality Engineering, Supplier Quality or similar roles, in areas like Electromechanical Instrumentation and Quality Assurance.
Minimum 5 years of experience leading a team.
Demonstrated expertise in manufacturing processes, quality systems, and product realization workflows.
Strong experience with design controls, process validation, and NPD/NPI integration to manufacturing.
Lead Auditor certification (ISO 9001, ISO 13485, or equivalent).
Background working with CMOs and external suppliers.
Strong analytical and problem-solving skills with demonstrated root-cause expertise.
Excellent verbal and written communication skills across multiple levels of the organization.
Strong project management skills; able to manage multiple priorities in a fast-paced environment.
Ability to influence cross-functional partners and drive alignment across diverse teams.