Manager of Quality Assurance

CMS 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. 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 SUMMARY

This position directs, guides and manages all aspects of Quality Assurance to achieve departmental execution and net value by optimizing risk, safety, financial, quality and productivity objectives, responsible for proactive and effective quality management. This position will be responsible for managing a staff of 20+ quality assurance inspectors and quality engineers in a Class 3 PMA medical device manufacturing company. An in-depth knowledge of FDA's Quality Management System Regulation and

ISO 13485

Quality Management System and

ISO 14971

is required. Areas of responsibility include, but are not limited to, the CAPA program, internal and external quality audits, and the nonconforming material process. The Manager will ensure sufficient staffing and resources are available to achieve business goals and compliance requirements. This position is also responsible for the creation and maintenance of written inspection instructions, performing trend analysis on various quality data, and presenting the reports to management. Job Type On Site 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. Comply with all policies and standards. Any other job responsibilities as assigned by management and subject to modification.

QUALIFICATIONS

Education Bachelor's Degree Required. Work Experience Minimum of 5 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. Requires in depth knowledge of 21 CFR 820, ISO 13485 quality system requirements and

ISO 14971.

Knowledge, Skills and Abilities Applied demonstrated advanced problem solving skills required. Ability to identify and develop strategies to address organizational weaknesses and meet organizational goals; Maintains knowledge and actively seeks out and develops best practices preferred. Licenses and Certifications ASQ Certified

CQE, CRE, CQM

• preferred Lean Six Sigma
• preferred

PHYSICAL DEMANDS/WORKING CONDITIONS

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 Environment While performing the duties of this job, the associate is required to work within the selected working environments. 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. #LI-KH1 The annual salary for this position is: $119,000.00 to $145,000.00 This position is eligible for an annual bonus in accordance with the company's bonus plan. 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. ZOLL Medical Corporation, an Asahi Kasei Group Company, develops and markets medical devices and software solutions that help advance emergency care and save lives, while increasing clinical and operational efficiencies. With products for defibrillation and monitoring, circulation and CPR feedback, data management, therapeutic temperature management, and ventilation, ZOLL provides a comprehensive set of technologies that help clinicians, EMS and fire professionals, and lay rescuers treat victims needing resuscitation and acute critical care. For more information, visit www.zoll.com. The Asahi Kasei Group is a diversified group of companies led by holding company Asahi Kasei Corp., with operations in the material, homes, and health care business sectors. Its health care operations include devices and systems for acute critical care, dialysis, therapeutic apheresis, transfusion, and manufacture of biotherapeutics, as well as pharmaceuticals and diagnostic reagents. With more than 30,000 employees around the world, the Asahi Kasei Group serves customers in more than 100 countries. For more information, visit www.asahi-kasei.co.jp/asahi/en/.