Site Leader, Quality Operations

• 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.

• 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
• Medical Device experience preferred

• 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

• English - Expert

• 5% Less than 5% travel locally, regionally or domestically.

• Standing - Occasionally
• Walking - Occasionally
• Sitting - Constantly
• Talking - Occasionally
• Hearing - Occasionally
• Repetitive Motions - Frequently

The annual salary for this position is:

This position is eligible for an annual bonus in accordance with the company's bonus plan. Factors which may affect starting salary include geography, skills, education, experience, and other qualifications of the successful candidate. Details of ZOLL's comprehensive benefits plans can be found at www.zollbenefits.com.

Applications will be accepted on an ongoing basis until this position is filled. For fully remote positions, compensation will comply with all applicable federal, state, and local wage laws, including minimum wage requirements, based on the employee's primary work location.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, or status as a protected veteran.

ADA: The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.