QA Automation Manager - w2

Experience: 15 years
Visa: USC//L2/TN/E2 (No H1&OPT)
Job type: w2 contract Position

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.

·         Serve as the primary quality escalation point for manufacturing concerns, ensuring rapid assessment and resolution.

·         Provide real-time quality support to production to maintain operational continuity while ensuring compliance.

·         Review and approve manufacturing deviations, rework instructions, and other quality-impacting actions, ensuring all quality decisions are risk-based, well-documented, and compliant with applicable standards and regulations.

·         Act 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 (The Individual 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.

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.

·         Proven experience architecting and delivering systems using agentic IDEs.

·         Ability / Experience (AI & Agentic IDEs)

·         Define architectural intent that agents can follow.

·         Break features into agent-executable tasks.

·         Govern AI autonomy (guardrails, permissions, reviews).

·         Integrate agentic workflows into CI/CD pipelines.

·         Experience supervising AI agents across multi-service systems.

·         Experience supervising AI agents in legacy modernization.

·         Experience supervising AI agents working with large codebases / monorepos.

·         Strong understanding of security implications of autonomous code execution.

·         Strong understanding of compliance, auditability, and traceability.

·         Strong understanding of AI-assisted SDLC operating models.

·         Core Responsibility (Agentic IDEs / AI-assisted SDLC)

·         Guide effective use of agentic IDEs for complex, multi-module or cross-service changes.

·         Establish review practices and quality checks for AI-generated code.

·         Mentor team members on balancing autonomy, correctness, and maintainability in AI-assisted development.

·         Design system architectures that support AI-augmented and agentic development workflows.

·         Define guardrails, standards, and governance for the use of autonomous coding agents.

Evaluate impact of agentic IDEs on SDLC, CI/CD pipelines, security posture, and technical debt.