Manager, Quality Assurance

The Manager Quality Operations will work within the Quality Operations structure in a management capacity has responsibility for quality related activities which include but not limited to the following:

What You Will Do

• Lead the Quality Assurance team providing technical guidance and quality oversight across manufacturing and operations supports functions to drive continuous improvement and compliance.
• Partner with site leadership to ensure products consistently meet customer expectations regulatory requirements and applicable quality standards.
• Develop coach and retain a high-performing team while fostering a culture of inclusion accountability collaboration and employee engagement.
• Drive quality system compliance by partnering with functional leaders to establish communicate and maintain quality standards requirements and responsibilities.
• Lead site readiness activities and support internal corporate notified body FDA and other regulatory audits and inspections.
• Oversee the management of nonconforming products product and process deviations risk assessments corrective actions and preventive actions to ensure effective resolution and compliance.
• Monitor and improve Quality performance indicators including NCR CAPA compliance and operational quality metrics and implement corrective actions for adverse trends.
• Support the development and execution of local and global Quality Operations strategies that improve product quality operational efficiency risk management and regulatory compliance.

What You Need

• Bachelors degree in Engineering Science or a related technical discipline.
• Minimum 6 years of experience in a medical device pharmaceutical biomedical automotive or other regulated manufacturing environment.
• Experience leading quality assurance or quality operations activities within a regulated industry.
• Experience supporting FDA inspections notified body audits and other regulatory audits.
• Knowledge of global quality regulations standards and quality management systems.
• Working knowledge of quality tools including Statistical Process Control (SPC) Failure Mode and Effects Analysis (FMEA) Root Cause Analysis and Six Sigma methodologies.
• Experience managing nonconformances CAPAs quality investigations and risk assessments.
• Experience implementing quality improvement initiatives and driving organizational change.

Preferred Qualifications

• Masters degree in Business Management Engineering Science or an MBA.
• Experience leading and developing high-performing quality teams in a manufacturing environment.
• Experience establishing quality strategies and performance improvement programs across multiple sites or business units.
• Black Belt Green Belt or equivalent Lean/Six Sigma certification.
• Experience supporting global quality systems regulatory compliance initiatives and continuous improvement programs.
• Experience influencing cross-functional stakeholders and driving quality culture initiatives.

United States of America Pay Ranges:

• USN: $102600 - $171000 USD Annual

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