Quality Engineering Manager Optimisation

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry, and transfusion medicine. With over 6,000 employees and operations in more than 130 countries, we provide fast, accurate, and consistent testing from home to hospital, lab to clinic. Our culture prioritizes team member happiness, inspiration, and engagement, fostering meaningful connections to drive both employee well-being and business success.

About the role

The Quality Engineering Manager is a regional people leader within QuidelOrtho’s Global Quality & Compliance (GQ&C) organization. This role develops and leads a team of Quality professionals to ensure the implementation and continuous improvement of Quality systems, processes, and programs that support QuidelOrtho’s right to operate, business agility, innovation, and growth. The position provides direction and operational oversight across Quality Engineering, ensuring alignment with global regulatory requirements (ISO 13485, FDA 21 CFR 820, IVDR, and other applicable standards).

The Quality Engineering Manager leads a team supporting the manufacturing of in vitro diagnostic (IVD) devices, ensuring operational continuity through timely quality oversight. This role acts as the first line of quality response to manufacturing issues, oversees non-conforming product disposition, and ensures regulatory and quality system compliance for manufacturing actions. The manager drives harmonization, inspection readiness, and continuous improvement while fostering talent development and a culture of engagement, collaboration, and performance.

This position is onsite in Rochester, NY.

Responsibilities

• Lead, develop, and inspire a team of Quality professionals to achieve organizational and individual performance objectives.
• Establish clear priorities, assign responsibilities, and ensure effective resource allocation to meet business and compliance needs.
• Coach and mentor emerging Quality leaders and technical experts to build organizational capability and ensure robust succession planning.
• Model QuidelOrtho’s leadership principles by demonstrating collaboration, accountability, inclusion, and service mindset in all interactions.
• Provide technical, regulatory, and operational leadership to ensure Quality systems comply with ISO 13485, FDA 21 CFR 820, IVDR, and other applicable requirements.
• Partner with Manufacturing, R&D, Regulatory Affairs, Supply Chain, and other stakeholders to integrate Quality and Compliance principles throughout the product lifecycle.
• Ensure the team maintains a state of inspection readiness and supports successful engagement with regulatory agencies, notified bodies, and internal audits.
• Serve as the primary quality escalation point for manufacturing concerns, ensuring rapid assessment and resolution while providing real-time quality support to production to maintain operational continuity.
• Review and approve manufacturing deviations, rework instructions, and other quality-impacting actions, ensuring decisions are risk-based, well-documented, and compliant with applicable standards.
• Act as the quality authority for batch release support, as applicable.
• Support harmonization and standardization of Quality processes, procedures, and tools across sites and functions to strengthen compliance and efficiency.
• Promote a culture of continuous improvement by identifying opportunities for simplification, process excellence, and digital enablement within the Quality Management System (QMS).
• Monitor Quality performance using metrics and data analytics to identify risks, drive root cause analysis, and implement sustainable improvements.
• Perform other work-related duties as assigned.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, or a related technical discipline required.
• 7+ years of progressive experience in Quality, Compliance, or related fields within the Medical Device, IVD, or Biopharmaceutical industries, including at least 3 years in people leadership.
• Understanding of Quality System regulations and standards, including ISO 13485, FDA 21 CFR 820, and IVDR.
• Proven ability to lead and develop high-performing teams and build future technical and people leaders.
• Demonstrated success driving Quality and Compliance initiatives that align with business strategy and regulatory expectations.
• Excellent collaboration, influence, and communication skills across functional and organizational boundaries.
• Strong analytical and problem-solving skills, with experience using data to drive decision-making and improvement.
• Experience leading in a matrixed, global organization and managing competing priorities effectively.
• Commitment to scientific integrity, compliance excellence, and continuous improvement.

Preferred Qualifications

• Advanced degree (MS, PhD, MBA, or equivalent) in a relevant discipline.
• Experience implementing or optimizing global Quality Management Systems (QMS) and digital tools.
• Lean Six Sigma, PMP, or similar certification demonstrating process improvement expertise.
• Experience supporting or leading Health Authority or Notified Body inspections.

Key Interactions

• Internal: Operations, Supply Chain, R&D, Commercial, Regulatory Affairs, GSO, Quality & Compliance teams globally and regionally.
• External: Regulatory agencies, Notified Bodies, Contract manufacturers, Suppliers, and service providers.

Work Environment

The work environment characteristics are representative of a manufacturing, laboratory, or warehouse setting. Physical demands include standard activities such as sitting, standing, walking, talking, hearing, and visual work. Occasional travel may be required for site visits, leadership meetings, or regulatory support.

Culture

At QuidelOrtho, our culture is shaped by four core behaviors that guide how we collaborate, make decisions, and support each other and those we serve:

• Thrive Together: Collaborate intentionally, grow as a team.
• Make It Happen: Focus on priorities, embrace continuous improvement.
• Commit to Service: Cultivate a service mindset.
• Embrace Inclusion: Be open and authentic, welcome diverse perspectives.

Pay

Salary range for this position is $102,000 to $133,000 and is bonus eligible. The range takes into account factors such as education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and market alignment.

Benefits

• Comprehensive medical, dental, and vision insurance.
• Life and disability insurance.
• 401(k) plan.
• Employee assistance program.
• Employee Stock Purchase Plan.
• Paid time off (including sick time) and paid holidays.