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
Benefits
Health insurance
Additional Information
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.
Zoll · Pittsburgh, PA