Manager, Quality Assurance (Fixed Term - 18 months)
Summary
Manages a quality assurance team in a medical device manufacturing environment, ensuring compliance with regulations and driving continuous improvement in product quality and operational processes.
The Manager, Quality Operations will oversee quality-related activities within the Quality Operations structure in a management capacity, including 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
- Bachelor's 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
- Master's 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: $118,000 - $196,700 USD Annual
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