Quality Assurance Technician

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 Type

On Site

Job Summary

This task-oriented role is a technical resource supporting business process and systems. Working with project stakeholders in all business areas, the Quality Technician will help with the development of flow map diagrams, operational and technical requirements, user acceptance testing script writing and test plans and validations.

Essential Functions

• Provides subject matter expertise in order to resolve complex inventory Discrepancies and (ERP/MES) system anomalies in order to make corrections according to quality assurance and materials management.
• Responsible for leading inspection non-conformance activities, and proposing the disposition to the material review board.
• Provides subject matter expertise to engineering around new product development and special inspection information requests.
• Facilitates the development, sustainment, and continuous improvement of quality systems and processes.
• Supports ERP (Epicor) / MES (Camstar) processes as a "super user".
• Facilitates MES (Camstar) / ERP (Epicor) validation activities in an IS0-13485/FDA regulated environment.
• Supports product and process change implementation by evaluating and completing necessary system validations and supporting documentation updates.
• Responsible for inspection of highly complex electrical and mechanical parts and assemblies.
• Responsible for the generation of inspection reports.
• Responsible for facilitating the disposition of nonconforming material.
• Responsible for creating and revising inspection instructions.
• Responsible for performing internal quality audits.
• Participate and coordinate QA activities during inventory counts.
• Responsible for performing moderately to highly complex MRP searches and transactions as related to QA.
• Responsible for clearly communicating relevant QA operational problems to the QA manager and other department managers within operations.
• Responsible for adhering to quality policies and procedures.
• Responsible for managing moderate to complex tasks with minimal direction.

Required/Preferred Education and Experience

• Degreed with up to 1 year quality management experience or high school diploma with 5 years relative quality assurance or engineering work experience.

Knowledge, Skills and Abilities

• General working knowledge of using a computer PC.
• Valid IPC-A-610 certification required at time of hire.
• Must be comfortable, quick, and accurate with data entry in applications such as MS Access and MS Excel.
• May be required to obtain AAMI Quality System Training
• May be required to obtain a Six Sigma Green Belt
• Must be a qualified internal auditor for auditing the internal Quality System.
• Must be able to read parts lists, manufacturing drawings, wiring diagrams or schematics and engineering change notices.
• Must be familiar with the use of electrical test equipment used to determine voltages, locate short circuits, incomplete connections and similar discrepancies.
• Must be familiar with the use of measurement equipment (calipers, micrometers, pin gages, etc).
• Must be able to identify components by color code or part markings.

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

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.

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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.