ZOLL Cardiac Management Solutions · 1 month ago
Site Leader, Quality Operations
US WI Deerfield
Full-time
Onsite
Senior Level, Lead/Staff
$130K/yr - $160K/yr
8+ years expZOLL Cardiac Management Solutions is dedicated to improving patient outcomes through innovative medical technologies. The Site Leader for Quality Operations will oversee the quality assurance and quality control strategies at a manufacturing site, ensuring compliance with regulations and leading efforts to enhance product quality and customer satisfaction.
Medical Device
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
Comply with all policies and standards
Any other job responsibilities as assigned by management and subject to modification
Qualification
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
Excellent leadership and people management skills, with the ability to motivate and develop high-performing teams
Working knowledge of relevant regulatory standards and requirements, such as FDA Quality System Regulation (QSR), ISO 13485, ISO 14971 and other applicable global regulations
Strong understanding of quality management systems, statistical process control, risk management, and validation processes
Strong analytical and problem-solving abilities, with a focus on data-driven decision-making
Exceptional communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams, senior management, regulatory bodies, and external stakeholders
Proficient in coordinating and hosting internal and external audits and interacting with regulatory authorities and notified bodies during inspections
Strong computer skills, including MS Office suite
Preferred
Medical Device experience preferred
English - Expert
Company
ZOLL Cardiac Management Solutions
ZOLL Cardiac Management Solutions (CMS), a division of ZOLL Medical Corporation, offers a unique portfolio of novel technologies designed to deliver better insights and better outcomes in cardiac patient care.
1001-5000 employees
H1B Sponsorship
ZOLL Cardiac Management Solutions 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
2024 (1)
2022 (1)
2021 (1)
2020 (2)
Funding
Current Stage
Late StageCompany data provided by crunchbase