Job Type

On Site

Job Summary

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.

Essential Functions

• 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. This role may also lead company-wide strategy and processes for CAPA, risk management, change control and PLM.

Required/Preferred Education and Experience

• Bachelor's Degree required Master's Degree in Engineering or MBA preferred.
• Minimum of 7 years 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 - preferred

Knowledge, Skills and Abilities

• Requires 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 preferred.
• 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

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• 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

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

Applications will be accepted on an ongoing basis until this position is filled. For fully remote positions, compensation will comply with all applicable federal, state, and local wage laws, including minimum wage requirements, based on the employee's primary work location.