QA Automation Manager - Medical Devices

Job Description

Role: QA Automation Manager

Locations:
Rochester, NY (5 days onsite)

Experience:

7+ years of progressive experience in Quality

• 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 Quidel Ortho 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.

• 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.

• 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.