Sr. Manager of Quality Assurance

At ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software, and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions. ZOLL Cardiac Management Solutions offers a unique portfolio of novel technologies designed to deliver better insights and better outcomes for cardiac patients globally.

About the role

The Senior Manager of Quality Assurance is a strategic leadership role responsible for ensuring the ongoing compliance, effectiveness, and continuous improvement of the Quality Management System (QMS) and products in a Class 3 PMA medical device manufacturing company. Reporting to the Director of Quality Assurance, this role oversees day-to-day QA operations, manages quality supervisors and engineering personnel, and ensures that all products and processes meet specified requirements and strict domestic and international regulatory standards, including FDA, QSR, ISO 13485, ISO 14971, European Medical Device Regulation (MDR), and ATF requirements.

Responsibilities

• Manages and maintains the inspection and product release programs for incoming and in-process materials and finished goods.
• Responsible for data collection and performance analysis of various quality metrics.
• Liaise with external inspectors/auditors.
• Responsible for monitoring QA processes and meeting production and department schedules (including audit and calibration).
• Manages the Quality Engineering and Inspection Departments.
• Serve as an escalation point for complex quality issues, champions cross-functional collaboration, and drives process adherence across the organization without compromising independent quality oversight.
• Responsible for the creation and maintenance of written inspection instructions, performing trend analysis on various quality data, and presenting the reports to management.
• May lead company-wide strategy and processes for CAPA, risk management, change control, and PLM.

Requirements

• Bachelor's Degree required; Master's Degree in Engineering or MBA preferred.
• Minimum of 7 years of management/leadership experience is required.
• A minimum of four years of experience as a quality assurance engineer or technical discipline in a medical device manufacturing environment, preferred.
• ASQ Certified CQE, CRE, CQM – preferred.
• Lean Six Sigma certification – preferred.

Skills

• In-depth knowledge of 21 CFR 820, ISO 13485 quality system requirements, MDR, and ISO 14971.
• Demonstrated ability to lead, develop, and engage high-performing teams, with a strong focus on talent development, accountability, and continuous improvement.
• Experience with Lean and Six Sigma principles such as Process Capability, Gage R&R, Design of Experiments, DMAIC, etc.
• Applied demonstrated advanced problem-solving skills.
• Proactive problem-solver with a strong sense of ownership and bias toward action.
• Ability to develop strategies to address organizational weaknesses and meet organizational goals; maintains knowledge and actively seeks out and develops best practices.
• Strong project management capabilities, including planning, prioritization, cross-functional coordination, and execution in complex environments.
• Advanced proficiency in data analysis, modeling, and decision support.
• Exceptional written and verbal communication skills, with the ability to clearly articulate ideas, influence stakeholders, and effectively communicate at all levels of the organization and with supplier partners.
• Highly organized and detail-oriented, with the ability to manage multiple priorities while maintaining accuracy and compliance.
• Self-directed and results-oriented, with the initiative to build subject matter expertise and serve as a trusted resource for the team and broader organization.

Physical Demands

• Standing – Constantly
• Walking – Constantly
• Sitting – Occasionally
• Lifting – Constantly
• Carrying – Constantly
• Pushing – Constantly
• Pulling – Constantly
• Talking – Occasionally
• Hearing – Frequently
• Repetitive Motions – Constantly
• Eye/Hand/Foot Coordination – Constantly

Working Conditions

• Extreme cold – Occasionally
• Extreme heat – Occasionally
• Humidity – Occasionally
• Wet – Occasionally
• Noise – Frequently

Pay

The annual salary for this position is $140,000.00 to $180,000.00. Factors which may affect starting salary include geography, skills, education, experience, and other qualifications of the successful candidate.

Benefits

Details of ZOLL's comprehensive benefits plans can be found at www.zollbenefits.com.