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 Acute Care Technology division of ZOLL develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Our dedicated employees take pride in their commitment to improving patient outcomes while delivering world-class customer service.

At ZOLL, you won't just have a job. You'll have a career-and a purpose.

Join our team. It's a great time to be a part of ZOLL!

Job Summary
The Principal Quality Assurance Compliance Engineer ensures all Corrective Action/Preventive Action (CAPA) and Internal Audit activities comply with ZOLL's Quality Management System (QMS). This individual will be responsible for identifying, analyzing, investigating, monitoring, and documenting patterns and trends in post-market surveillance data as part of the CAPA and Internal Audit systems, as well as communicating to Management, QA, R&D, Operations, and other departments regarding product performance, quality compliance, and system metrics. In addition, the Principal Quality Assurance Compliance Engineer will also be responsible for leading and coordinating all External Auditing, Quarterly Management Review, New Employee Training, and QMS Continuous Process Improvement activities.

Essential Functions

• Ensure all CAPA records are established, maintained, documented, and closed promptly and according to QMS procedures.

• Assist CAPA owners with investigations, action plans, and verification and validation activities.

• Assist owners in root cause analysis.

• Chair the monthly CAPA management meeting and provides metrics for CAPA status.

• Gather and analyze metrics to measure effectiveness and makes recommendations to improve the CAPA program.

• Coordinate the review of CAPAs to determine their effectiveness.

• Ensure on-time completion of CAPAs.

• Identify and execute opportunities for continuous improvement (Lean).

• Interface with FDA and third-party auditors during inspections.

• Oversee the internal audit program and the audit program's corrective actions.

• Ensure that all corrective actions from internal and external audits are practical and verified.

• Act as liaison with regulatory agencies to obtain information related to product standards and regulations.

• Lead quality system audits to ensure the QMS operates in a state of compliance and continuous improvement.

• Prepare audit reports and conduct audit briefings upon completion of audits.

• Document audit reports within specified time frames and generate audit corrective action requests as applicable.

• Follow, interpret, and develop written Policies and Standard Operating Procedures (SOP's).

• Monitor internal audit non-conformances, perform trend analyses, and present findings.

• Contribute to the development and improvement of audit program metrics.

• Report systemic quality system issues through the analysis of quality data such as CAPAs, complaints, MDR/Vigilance reports, audit reports, and other relevant data.

• Participate in process improvement activities to continuously improve process effectiveness.

• Review completed quality records to ensure completeness and adequacy. Discuss any encountered issues with Quality Management.

Required/Preferred Education and Experience

• Bachelor's Degree in Engineering preferred or

• Equivalent QA experience considered

• 5+ Years of Lead Auditor experience in the Medical Device industry required

• Experience using Microsoft Word and Excel preferred

• Certified Quality Auditor Required or

• ISO 13485:2016 Lead Auditor Certification

Knowledge, Skills and Abilities

• Ability to work under minimal supervision and have excellent time management skills

• Possess good interpersonal and interview skills, strong attention to detail, coupled with an uncompromising dedication to ethical, professional behavior

• Ability to interpret requirements to generate audit checklists in support of company and regulatory requirements

• Must be able to interpret and apply domestic and international regulations

• Possess proven negotiation and conflict resolution skills

• Excellent analytical, prioritization, and multitasking skills

• Ability to work with team members across functions/departments

• Ability to effectively present information to top management and team members

• Writes clearly and informatively; varies writing style to meet needs; presents numerical data effectively; able to read and interpret written information

• Demonstrates accuracy and thoroughness; applies feedback to improve performance

• Proven ability to lead/coordinate complex QMS integration/implementation projects/tasks

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.

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