Quality Assurance Engineer

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 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

Performs a variety of complex tasks related to Quality Assurance including, but not limited to: performing trend analyses on quality data to provide early warning of potential problems and improvement opportunities. Develop, implement, and manage value improvement projects which incorporate a Lean/Six-Sigma approach. Perform analyses on quality information to proactively improve potential problems and capture improvement opportunities including non-product software

Essential Functions

• Performs internal quality audits and effectiveness reviews (FDA's QSR, ISO 13485, MDD, CMDR) Conducts supplier evaluations and audits
• Responsible for the development and execution of Lean/six-Sigma and other cost improvement initiatives that can be related to product quality
• Responsible to understand the appropriate legal and regulatory requirements in the areas of medical device operations and to establish robust processes and controls to ensure compliance
• Responsible to build and improve key business relationships within the organization's cross functional departments
• Ensure operations quality measurement systems are capable (Gauge R&R), process capability (Cpk) is high and process controls are in place to assure that products meet specifications
• Ensure that equipment is calibrated and maintained in accordance with requirements, and that these activities are properly documented
• Conducts various risk analysis activities for new and existing products including FMEAs and Fault Tree Analyses
• Prepare, submit and coordinate the process validation requirements for non-product software validations
• Participates in the FDA premarket approval process (PMA) for new and modified medical devices
• Participates in the nonconforming material/Material Review Board process Championing the implementation of Lean Manufacturing processes
• Participate in Kaizen events as a representative of the quality department

Required/Preferred Education and Experience

• Bachelor's Degree Requires a BS degree or equivalent experience in a technical or scientific discipline. required
• Experience in an FDA regulated Class III electrical medical device manufacturing environment preferred.
  preferred and
• Experienced in process development and validation for electro-mechanical assembly, test, and service.
  required and
• Formal Project management experience a plus preferred and
• Lean experience preferred and
• Experience with database queries and reporting in SQL or Microsoft Access preferred
• Six Sigma Green Belt Certification Preferred or
• Black Belt Preferred

Knowledge, Skills and Abilities

• Understands and has applied in practice the concepts of process capability, process control, and measurement system capability.

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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• While performing the duties of this Job, the employee is regularly required to sit and talk or hear. The employee is occasionally required to stand; walk and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds.

Working Conditions

• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• The noise level in the work environment is usually quiet.

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's 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.

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All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.