The RoleAs we continue to grow as one QuidelOrtho we are seeking a Manager Quality Engineering Optimization. The Quality Engineering Manager is a regional people leader within QuidelOrtho' s Global Quality & Compliance (GQ&C) organization. This leader is responsible for developing and leading a team of Quality professionals to ensure the implementation, and continuous improvement of Quality systems, processes, and programs that enable QuidelOrtho' s Right to Operate and support business agility, innovation, and growth. This role 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 is responsible for leading a team of Quality Engineers supporting the manufacturing of in vitro diagnostic (IVD) devices. This role ensures operational continuity by providing timely and effective quality oversight. The position acts as the first line of quality response to manufacturing issues, oversees the disposition of non-conforming product, and ensures appropriate quality approval of manufacturing actions in compliance with regulatory and quality system requirements. The position leads quality engineers in key Quality Engineering (QE) principles, tools, and practices to develop and optimize process controls and quality system processes that are aligned with the overall business goals. The Quality Manager partners cross-functionally to embed Quality and Compliance principles throughout the product lifecycle, driving harmonization, inspection readiness, and continuous improvement. The role ensures the team partners cross functionally to identify opportunities for improvement, drive root cause investigations, and implement sustainable solutions that enhance product and process performance. This leader is also accountable for developing talent, strengthening scientific and compliance capabilities, and fostering a culture of engagement, collaboration, and performance. By integrating technical expertise, data-driven insights, and agile leadership behaviors, the Quality Manager ensures that Quality systems and teams deliver sustainable business and compliance outcomes.
This position will be onsite in Rochester, NY.
The 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 as applicable.
- Ensure the team maintains a state of inspection readiness and supports successful engagement with regulatory agencies, notified bodies, and internal audits.
- Team serves as the primary quality escalation point for manufacturing concerns, ensuring rapid assessment and resolution. Providing real-time quality support to production to maintain operational continuity while ensuring compliance.
- Team review and approve manufacturing deviations, rework instructions, and other quality-impacting actions. Ensuring that all quality decisions are risk-based, well-documented, and compliant with applicable standards and regulations. Acting 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.
The IndividualRequired:
- 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:
- 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 InteractionsInternal: 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 EnvironmentThe work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment.
The Physical DemandsNo strenuous physical activity. Standard activities include sitting, standing, walking, talking, hearing, and visual work. May include occasional travel for site visits, leadership meetings, or regulatory support.
How We WorkAt QuidelOrtho, our culture is shaped by four core behaviors that guide how we collaborate, make decisions, and support each other and those we serve. The ideal candidate will exhibit these behaviors, as we believe they're essential to how we thrive as a team and achieve meaningful impact:
- 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
Salary TransparencySalary range for this position takes into account a wide range of factors including: education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on that facts and circumstances of each case. Salary range for this position is $102,000 to $133,000 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time) and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate.
