Job Title: Quality Leadership and Technical Guidance
Provide quality leadership and technical guidance on preventative quality within operations and other business functions at local and global levels, advocating and leading the execution of initiatives & projects to enhance quality performance within the business.
About This Role
* Work closely with business functions to assess, provide oversight, and direction on quality performance of products and processes.
* Mentor, provide oversight, and approval of NC & CAPA; act as a high-level expert in problem-solving and root-cause analysis activities.
* Coach and mentor the quality team and other business functions in quality topics and activities, with several topics at the expert level.
* Lead/manage quality initiatives/projects at local & global levels.
* Be a recognized process owner in areas of expertise, including problem-solving, risk management, concession & change management, lean, six sigma, CAPA, statistics, validation, inspection processes & sampling, etc.
* Provide input into local, global & corporate processes; serve as a representative on review & discussion boards and teams for expert & valued input.
* Provide input/assessment and justification at the expert level during concession/change management and quality issues; review and approve the same, driving strong review processes.
* Interpret KPI trends, take action as necessary, driving a continuous improvement process.
* Advocate for Human Factor practices; be proficient in the science of Human Factor identification and mitigation.
* Participate in and may lead internal & external audits with regulatory representatives, providing effective narrative and description of topics of expertise and overview of the business; oversee/deputize for audit management, logistics, and preparation as required.
* Aid in the development of validation strategies; be certified in multiple disciplines of validation to approval level.
* Support/lead manufacturing transfers to other plants/facilities, leading quality activities.
Requirements
* Level 8 Degree
* 6 years of experience
Estimated Salary:
$150,000 - $200,000 per year