The Opportunity
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.
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. Join us in our mission to transform the power of diagnostics into a healthier future for all.
The Role
As we continue to grow as QuidelOrtho, we are seeking a Supervisor, Incoming Inspection East Coast. The Supervisor, Incoming Material Inspection – East Coast is a people leader within QuidelOrtho' s Global Quality & Compliance (GQ&C) organization, responsible for leading Incoming Material Inspection activities across East Coast operations. Reporting to the Manager, Incoming Material Inspection, this role ensures effective execution, oversight, and continuous improvement of incoming inspection processes to support manufacturing, protect product quality, and maintain QuidelOrtho' s Right to Operate. This leader provides operational leadership for the East Coast Incoming Inspection team, ensuring that raw materials, components, and consumables meet defined quality, regulatory, and technical requirements prior to release for manufacturing. The Supervisor partners cross-functionally with Manufacturing, Supply Chain, Supplier Quality, and other stakeholders to ensure alignment to global standards while addressing site-specific needs. The role ensures compliance with global regulatory requirements (ISO 13485, FDA 21 CFR 820, IVDR, and other applicable standards), while driving consistency, efficiency, and inspection readiness across East Coast operations. This position plays a critical role in translating global strategies and standards into effective local execution. In addition, this leader is responsible for developing talent, strengthening technical and compliance capabilities, and fostering a culture of accountability, engagement, and continuous improvement. Through strong leadership, data-driven decision-making, and collaboration, the Supervisor ensures high-quality execution and sustainable business outcomes.
This position can be in Rochester, Athens or Pompano.
The Responsibilities
- Lead, coach, and develop a team of Quality professionals to ensure strong performance, engagement, and capability building.
- Set clear priorities, manage daily operations, and allocate resources to meet business and compliance needs.
- Foster a culture of accountability, speak-up, and continuous improvement aligned with GQ&C principles.
- Ensure effective execution of incoming inspection processes for raw materials, components, and consumables supporting East Coast manufacturing sites.
- Ensure timely and compliant material disposition to support manufacturing without compromising quality.
- Execute inspection strategies, sampling plans, and acceptance criteria in alignment with global standards.
- Ensure adherence to global regulatory requirements (ISO 13485, FDA 21 CFR 820, IVDR, and applicable standards).
- Maintain a state of inspection readiness and support internal audits, regulatory inspections, and notified body engagements.
- Ensure accurate and compliant documentation, data integrity (ALCOA+), and traceability within the QMS.
- Partner with Manufacturing, Supply Chain, Supplier Quality, R&D, and Regulatory Affairs to ensure material quality requirements are defined, understood, and met.
- Support supplier-related activities including material qualifications, changes, deviations, and investigations impacting incoming materials.
- Participate in risk assessments and material control strategies for new product introductions and product changes.
- Monitor performance using metrics and data analytics to identify trends, risks, and improvement opportunities.
- Drive simplification, standardization, and elimination of non–value-added activities within incoming inspection processes.
- Support harmonization initiatives by implementing global procedures, tools, and best practices at the site level.
- Translate and implement global Incoming Inspection strategies, processes, and standards within East Coast operations.
- Provide feedback to the Manager and global leadership on site performance, risks, and opportunities to inform continuous improvement and harmonization efforts.
- Perform other work-related duties as assigned.
The Individual
Required
- Bachelor’s degree in Life Sciences, Engineering, or a related technical discipline required.
- 5+ years of progressive experience in Quality, Compliance, or related fields within the Medical Device, IVD, or Biopharmaceutical industries, with preferred people leadership experience.
- Strong understanding of Quality System regulations and standards, including ISO 13485, FDA 21 CFR 820, and IVDR.
- 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
- Lean Six Sigma, PMP, or similar certification demonstrating process improvement expertise.
- Experience supporting or leading Health Authority or Notified Body inspections.
The Key Working Interactions
Internal: Operations, Supply Chain, R&D, Commercial, Regulatory Affairs, and other Quality & Compliance teams globally and regionally.
External: Regulatory agencies, notified bodies, contract manufacturers, suppliers, and service providers.
The Work Environment
Typical office or laboratory environment. May involve virtual collaboration across multiple global sites.
The Physical Demands
No strenuous physical activity required. May include occasional travel for site visits, leadership meetings, or regulatory support.
Salary Transparency
The salary 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 the facts and circumstances of each case. The salary range for this position is $89,000 to $115,000 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.
Equal Employment 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.
