CMSAt 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. On any given day, clinicians utilize these ZOLL products for tens of thousands of cardiac patients around the world:
- LifeVest, the world's first wearable defibrillator, has been trusted to protect more than 1M patients at risk of sudden cardiac death.
- HFMS (Heart Failure Management system) is a non-invasive, patch-based device that monitors pulmonary fluid levels and has been shown to reduce heart failure readmissions rates by 38 percent.
- TherOx Super Saturated Oxygen (SSO2) Therapy is the first FDA-approved therapy since the stent 20+ years ago to reduce infarct size in patients with the most severe heart attacks.
Heart disease is the leading cause of death for both men and women in the U.S. At ZOLL, your work will help to ensure cardiac patients get the life-saving therapy they need.
ZOLL has been Pittsburgh's Manufacturer of the Year, one of Western PA's Healthiest Employers, and even one of Pittsburgh's Coolest Offices. But it's our unique opportunity to impact people's lives that makes ZOLL the ideal place to build your career.
Job TypeOn Site
Job SummaryThe 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.
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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 DemandsThe 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
ZOLL is a fast-growing company that operates in more than 140 countries around the world. Our employees are inspired by a commitment to make a difference in patients' lives, and our culture values innovation, self-motivation and an entrepreneurial spirit. Join us in our efforts to improve outcomes for underserved patients suffering from critical cardiopulmonary conditions and help save more lives.
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.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, or status as a protected veteran.
ADA: The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.
