Supervisor, Incoming Inspection, East Coast

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 more than 6,000 employees operating in over 130 countries, the company delivers fast, accurate, and consistent testing wherever it is needed—from home to hospital, lab to clinic. The culture puts team members first, prioritizing happiness, inspiration, and engagement, and believes that employee well‑being drives business success.

About the role

The Supervisor, Incoming Material Inspection – East Coast is a people leader within QuidelOrtho’s Global Quality & Compliance (GQ&C) organization. Reporting to the Manager, Incoming Material Inspection, this role leads Incoming Inspection activities across East Coast operations, ensuring raw materials, components, and consumables meet defined quality, regulatory, and technical requirements before release for manufacturing. The position can be based in Rochester, Athens, or Pompano and partners cross‑functionally with Manufacturing, Supply Chain, Supplier Quality, R&D, and Regulatory Affairs to align global standards with site‑specific needs.

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.
• Maintain adherence to global regulatory requirements (ISO 13485, FDA 21 CFR 820, IVDR, and applicable standards).
• Maintain 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 define and meet material quality requirements.
• Support supplier‑related activities including material qualifications, changes, deviations, and investigations.
• 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.
• Perform other work‑related duties as assigned.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, or a related technical discipline.
• 5+ years of progressive experience in Quality, Compliance, or related fields within the Medical Device, IVD, or Biopharmaceutical industries.
• 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; 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 certifications: Lean Six Sigma, PMP, or similar process‑improvement credentials.
• Experience supporting or leading Health Authority or Notified Body inspections.

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.

Work Environment

Typical office or laboratory environment. May involve virtual collaboration across multiple global sites.

Physical Demands

No strenuous physical activity required. May include occasional travel for site visits, leadership meetings, or regulatory support.

Pay

The salary range for this position is $89,000 to $115,000 and is bonus eligible.

Benefits

• Medical, dental, vision, life, and disability insurance
• 401(k) plan
• Employee assistance program
• Employee Stock Purchase Plan
• Paid time off (including sick time)
• Paid holidays