Quality Lead, Requirements and Specifications Management (Assay)

The Role

The Quality Lead, Requirements and Specifications Management (Assay) is a global individual contributor within QuidelOrtho's Global Quality & Compliance (GQ&C) organization. This role is responsible for ensuring 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. This role provides strategic direction and operational oversight across product lifecycle quality with responsibility for defining, owning, and continuously improving the end-to-end requirements and specifications framework for a portfolio of assay-based medical device products.

• Establish clear priorities, assign responsibilities, and ensure effective resource allocation to meet business and compliance needs.
• Provide technical, regulatory, and operational leadership to ensure Quality systems comply with ISO 13485, FDA 21 CFR 820, IVDR, and other applicable requirements.
• Drive 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).
• Ensure the team maintains a state of inspection readiness and supports successful engagement with regulatory agencies, notified bodies, and internal audits.
• 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.
• Communicate Quality and Compliance strategy, progress, and risk mitigation plans to senior leadership and cross-functional stakeholders.

Responsibilities

Establish clear priorities, assign responsibilities, and ensure effective resource allocation to meet business and compliance needs.

Provide technical, regulatory, and operational leadership to ensure Quality systems comply with ISO 13485, FDA 21 CFR 820, IVDR, and other applicable requirements.

Drive 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).

Ensure the team maintains a state of inspection readiness and supports successful engagement with regulatory agencies, notified bodies, and internal audits.

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.

Communicate Quality and Compliance strategy, progress, and risk mitigation plans to senior leadership and cross-functional stakeholders.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or a related technical discipline.
• 7+ years of progressive experience in Quality, Compliance, or related fields within the Medical Device, IVD, or Biopharmaceutical industries.
• Strong understanding of Quality System regulations and standards, including ISO 13485, FDA 21 CFR 820, and IVDR.
• 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.
• Commitment to scientific integrity, compliance excellence, and continuous improvement.

Skills

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

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.

Pay

$135,000 to $175,000 and is bonus eligible.

Schedule

Onsite in Rochester, NY.