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ZOLL Medical Corporation · 2 days ago

Site Leader, Quality Operations

Deerfield, WI

Full-time

Onsite

Senior Level, Lead/Staff

$130K/yr - $160K/yr

8+ years exp

ZOLL Medical Corporation is dedicated to improving patient outcomes through innovative medical technologies. The Site Leader for Quality Operations will oversee the quality assurance and control strategies at a manufacturing site, ensuring compliance with regulations and enhancing product quality.

Health CareMedical DeviceSoftware

H1B Sponsor Likely

Responsibilities

Implement, improve and maintain an effective QMS that complies with relevant regulations and industry standards, such as ISO 13485 and FDA requirements

Collaborate with other ACT quality site leads to ensure the integrated QMS is functioning as intended at the site level and across sites

Lead efforts to continuously improve quality system processes and procedures to enhance product quality, reduce defects, and increase customer satisfaction

Responsible for leading facility internal and external audits to a successful outcome

Prepares and attends Quarterly Management Review and QA staff meetings

Provide leadership, guidance, and mentorship to the quality assurance team, including hiring, training, performance management, and professional development

Promote a culture of quality throughout the organization by providing training, guidance, and support to all employees, and by fostering a proactive and accountable approach to quality and regulatory compliance

Ensure that new products and changes to existing products are implemented in accordance with the organization's Quality Management System

Work with Quality Engineering resources to complete investigations into product non-conformances and customer complaints, implement appropriate corrective and preventive actions (CAPAs), and track their effectiveness

Provide guidance on validation activities, including approach, sampling plans, and deviation resolution. Delegation of protocol and report approvals

Support the risk management program and practices to identify and mitigate potential risks associated with product quality

Develop and implement robust quality control processes to monitor and evaluate product quality, ensuring adherence to specifications and standards

Develops and prepares weekly/monthly/quarterly/annual reporting on Quality KPls, support and improvement activities

Stay up-to-date with relevant regulations and standards in the medical device industry, and ensure the site's compliance with all applicable regulations, including FDA, EU MDR, and other global regulatory requirements

Establishes annual improvement/Quality Objectives for the site in coordination with other site leads

Conduct annual and ongoing performance reviews with recommendations for compensation changes, promotions, and disciplinary action as appropriate

Set a professional example in alignment with ZOLL’s Leadership Qualities

Qualification

Quality Management SystemFDA regulationsISO 13485Risk managementStatistical process controlLeadership experienceComputer skillsCommunication skillsProblem-solving abilitiesInterpersonal skillsTeam management

Required

Bachelor's Degree in engineering, life sciences, or equivalent required

1-3 years of leadership experience required

7-9 years QMS experience in a regulated environment required

Experience with implementing and/or maintaining quality systems in accordance with FDA regulations and international standards required

Preferred

Medical Device experience preferred

English - Expert

Benefits

This position is eligible for an annual bonus in accordance with the company's bonus plan.

Details of ZOLL's comprehensive benefits plans can be found at www.zollbenefits.com.

Company

ZOLL Medical Corporation

Glassdoor3.3

ZOLL Medical Corporation, an Asahi Kasei Group Company, develops and markets medical devices and software solutions that help advance emergency care and save lives, while increasing clinical and operational efficiencies.

Founded in 2004

Pittsburgh, Pennsylvania, USA

1001-5000 employees

https://www.lifevest.zoll.com

H1B Sponsorship

ZOLL Medical Corporation has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (13)

2024 (6)

2023 (8)

2022 (8)

2021 (2)

2020 (6)