QA Automation Manager Medical Devices

Role: QA Automation Manager

Locations: Rochester NY ( 5 days onsite)

Experience: 7 years of progressive experience in Quality

JD:

The Responsibilities

• 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 QuidelOrthos 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.

Required:

• Bachelors 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.

Preferred:

• 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.