QuidelOrtho
Quality Lead,
US - NY - Rochester
Sponsorship not specified$135k-$175kDetected 9 days ago
Data AnalysisProduct ManagementSupply ChainProcess ImprovementSystems EngineeringFDA RegulatoryMedical DevicesLeadershipCommunicationCollaborationProblem SolvingLean ManufacturingRegulatory Affairs
About the role
- 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.
- We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic.
- Join us in our mission to transform the power of diagnostics into a healthier future for all.
Responsibilities
- Thrive Together - Collaborate intentionally, grow as a team
- This individual is responsible to ensure the design, implementation, and continuous improvement of Quality systems, processes, and programs that enable QuidelOrtho' s Right to Operate and support business agility, innovation, and growth.
- By integrating technical expertise and data-driven insights, the Quality Lead ensures that Quality systems deliver sustainable business and compliance outcomes.
- Partner with Manufacturing, R&D, Regulatory Affairs, Supply Chain, and other stakeholders to integrate Quality and Compliance principles throughout the product lifecycle.
- Monitor Quality performance using metrics and data analytics to identify risks, drive root cause analysis, and implement sustainable improvements.
- Coach and mentor emerging Quality team members to build organizational capability and ensure robust succession planning.
- May include occasional travel for site visits, leadership meetings, or regulatory support.
Requirements
- Bachelor's degree in Life Sciences, Engineering, or a related technical discipline.
- Strong understanding of Quality System regulations and standards, including ISO 13485, FDA 21 CFR 820, and IVDR.
- No strenuous physical activity required.
- Advanced degree (MS, PhD, MBA, or equivalent) in a relevant discipline.
Skills
- Establish clear priorities, assign responsibilities, and ensure effective resource allocation to meet business and compliance needs.
- Communicate Quality and Compliance strategy, progress, and risk mitigation plans to senior leadership and cross-functional stakeholders.
- Perform other work-related duties as assigned.
Compensation
- Salary Transparency
Benefits
- Experience supporting or leading Health Authority or Notified Body inspections.
- Salary range for this position is $135,000 to $175,000 and is bonus eligible.
Company info
- As we continue to grow as one QuidelOrtho we are seeking a Quality Lead, Requirements and Specifications Management (Assay).
- 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.
- Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement.
- We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked.
- Embrace Inclusion - Be open and authentic, welcome diverse perspectives
Equal opportunity
- QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic.
- QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their duties.
- If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at recruiting@quidelortho.com.
Visa & Work Authorization
- r those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic info
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This listing is sourced directly from QuidelOrtho's careers page and normalized into a canonical job model.