Senior Director, Site Quality Head- Newark, DE

About the role

As the Senior Director, Site Quality Head, you'll define and execute the site's quality strategy, develop top‑tier talent, and ensure world‑class regulatory excellence. You will be the catalyst for digital transformation, continuous improvement, and harmonized quality practices across our global network.

Responsibilities

• Set the quality vision and align the site to global standards and enterprise strategy.
• Lead, coach, and grow a skilled team of managers, engineers, and QC leaders.
• Drive regulatory excellence and ensure readiness for audits, inspections, and IVD compliance.
• Modernize quality systems, champion digitalization, and accelerate continuous improvement.
• Collaborate globally to harmonize processes and elevate quality maturity across sites.
• Partner cross‑functionally to embed quality thinking into operations and strategic planning.
• What You Bring
• 8+ years senior leadership experience in quality or manufacturing within IVD, medical devices, pharma, or similar regulated industries.
• Bachelor's degree in Engineering or Life Sciences.
• Strong knowledge of ISO 13485, IVDR, 21 CFR 820, and diagnostic manufacturing expectations.
• Proven ability to inspire teams, build capability, and develop future leaders.
• A data‑driven approach with experience using digital tools or analytics to improve quality performance.
• Professional certifications such as Certified Quality Manager or Six Sigma Black Belt are a plus.
• Lead with Purpose. Deliver Global Impact.
• Join us and help drive breakthroughs in healthcare-everywhere, for everyone. Become the leader who shapes the next era of reagent manufacturing quality.
• #LI-BH1
• To find out more about Siemens Healthineers businesses, please visit our company page here .
• The base pay range for this position is:
• $189,950 - $261,184
• Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.
• If this is a commission eligible position the commission eligibility will be in accordance with the terms of the Company's plan. Commissions are based on individual performance and/or company performance.
• EEO is the Law: Applicants and employees are protected under Federal law from discri

Benefits

Additional Information

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions. Own the Quality Vision. Shape a Global Impact. Lead What's Next in Diagnostics. If you're a transformative quality leader ready to influence not just one site-but the global future of IVD manufacturing-this is your moment. Step into a role where your decisions elevate patient safety, strengthen global standards, and drive innovation across an international reagent manufacturing network.

Your Match

How well this role fits your profile.

Company Intel

What employees say

Worked at onehealthineers? Share your experience