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.
The Circulation division of ZOLL Medical Corporation is focused on "beating heart" therapies for hospitals. Post-cardiac arrest, STEMI heart attack, and severe fever are some of the applications of ZOLL's unique devices. Fully integrated, ZOLL Circulation researches, develops, manufactures, and sells novel technologies includes ZOLL Temperature Management Solutions and TherOx SSO2 Therapy. Temperature Management Solutions empower physicians to "prescribe" a temperature and achieve it. TherOx 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.
Job Summary
Responsible for the required maintenance of ZOLL Documentation, Training, and calibration processes.
Essential Functions
- Maintain calibration files and calibration database.
- Coordinating with equipment owners across departments to obtain and send out instruments to be calibrated by external service providers.
- Managing shipment and logistics for all instruments and standards sent off-site for calibration and/or repair. Following up with vendors to ensure a timely return of equipment once it has been serviced.
- Reviewing calibration worksheets and certificates for completeness and accuracy, and documenting work electronically within MQMS System
- Ensuring OOT events are reported in a timely manner and that all necessary documentation is available to facilitate closure of the associated deviation investigations.
- Review calibration and maintenance activities and schedule needed work within the team while coordinating with clients as needed.
- Perform tracking and recovery to ensure that customers’ on-time deliveries are archived.
- Manages filing and updating information quality system documentation.
- Manages the database controlling documentation.
- Files and maintains the standards library.
- Posts change to computerized or manual control records, releases documents, and notify affected departments.
- Manages complex document control projects like labeling revision and localization.
- Maintains the training database.
- Supports general administration across the QA department (e.g., Post-Market Surveillance, compliance-related tasks, etc.)
- Responsible for all product recall-related administrative/reporting tasks
Required/Preferred Education and Experience
- High School Degree with related experience in documentation control; or equivalent experience. Previous experience in quality functions for the medical devices industry is preferred.
Knowledge, Skills and Abilities
- Strong attention to detail
- Works well independently as well as with a team
- Listens and obtains clarification as needed.
- Writes clearly and imformatively
- Follows policies and procedures
- Exhibits sound and accurate judgement
- Basic working knowledge of desktop computer applications and tools such as Solidworks, LabView, schematic capture tools
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 - Occasionally
- Walking - Occasionally
- Sitting - Constantly
- Talking - Occasionally
- Hearing - Occasionally
- Repetitive Motions - 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.
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.