Quality Assurance Leadership Opportunity
We are seeking a skilled Quality Assurance Leader to provide overall quality assurance leadership in the management of contract manufacturing sites and raw material suppliers.
Key Responsibilities:
* Support quality systems including change control, supplier non-conformances, ASL management, quality agreements and department procedures and systems.
* Perform and support supplier/EM quality evaluations and/or audits, development of quality agreements, and other quality-related activities impacting suppliers.
* Lead activities associated with resolving supplier quality issues, root cause analysis/failure investigations, identifying and implementing corrective actions, and monitoring for effectiveness.
* Lead activities associated with supplier risk management, establishing, monitoring and implementing supplier risk mitigation plans, participating in supplier risk management projects, and ensuring management awareness of risks, gaining support for mitigation efforts and tracking progress.
* Provide quality engineering support to suppliers including assessments, inspection technique support, verification/validation activities, CAPA and change management.
* Develop and report on supplier performance metrics, participate in local site supplier quality meetings to ensure communication and alignment of quality initiatives.