Site Leader, Quality Operations

ZOLL Medical • Deerfield, IL

2d • $130,000 - $160,000

About The Position

This position is responsible for the overall leadership and execution of the quality assurance and quality control strategy, programs and policies for a ZOLL manufacturing site. Oversee multiple shifts for Quality support to meet the daily, weekly, and monthly requirements for Production Schedule and customer attainment.

Requirements

• Bachelor's Degree in engineering, life sciences, or equivalent required
• 1-3 years of leadership experience required and
• 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

Nice To Haves

• Medical Device experience preferred

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.

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 .

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees