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PMP
Lead
QA
Medical devices
quality
Quality Engineer
FDA
ISO
Six Sigma

Summary

Job description

Role: QA Automation Manager

Locations: Rochester, NY

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 QuidelOrtho'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.

Required:

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.

PSRTEK is a reputed technology recruitment and IT staffing brand with a global footprint and an admired client base. As an ideas and innovation powerhouse with a culture of excellence, we bring remarkable expertise and deliver powerfully transformative results.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91098474
Position Id: 2026-2177
Posted 2 days ago

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QE Lead/ QE Manager at Rochester, NY

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