CDx Design Quality Senior Manager

Job Description

The Companion Diagnostics (CDx) Design Quality Manager leads a team of CDx Design Assurance Specialists and is accountable for design quality across the CDx portfolio. This role oversees design controls, risk management, verification and validation, clinical performance evaluation, and development quality activities to ensure products meet applicable quality, regulatory, and business requirements.

As the primary quality representative for the CDx business, the Design Quality Manager serves as the liaison between Global Quality and CDx, driving alignment, escalating key issues and successes to the Associate Vice President, Quality, Science & Technology (QSAT) for Medical Devices, and collaborating with internal stakeholders and external partners, including pharmaceutical companies.

The Design Quality Manager champions a strong culture of quality and compliance, proactively identifying risks and implementing measures to maintain and continuously improve quality performance across the organization.

This position is responsible for resource planning, project oversight, and cross-functional coordination of quality activities across CDx development programs and partner collaborations. The role ensures projects are executed within established timelines and budgets while meeting all quality requirements, product specifications, and regulatory expectations.

Key responsibilities include:

• Ensuring effective implementation and execution of design controls, risk management, and quality processes throughout product development.

• Providing quality leadership and oversight for CDx development projects, including the timely resolution of quality-related issues.

• Approving quality documents, procedures, and records, as required.

• Maintaining and continuously improving Quality Management System (QMS) processes and systems within the area of responsibility.

• Supporting product investigations, field actions, and interactions with regulatory agencies, as needed.

• Leading and contributing to QMS improvement initiatives that enhance compliance, efficiency, and product quality.

• Providing expertise, coaching, training, and consultation on quality systems, processes, and methodologies to strengthen a customer-focused quality culture.

Job Responsibilities:

• Manage the design assurance team as they support quality oversight and approval of development processes and strategies throughout the development lifecycle for multiple development projects

• Ensure that development teams are supported to complete design assurance activities, including review and approval of development planning, execution, commercial launch, V&V testing, risk management, etc. 

• Gather input to risk management, implementation of new design control or design and development processes and manage high level changes and initiatives that impact all development projects and the CDx organization as a whole.

• Ensure that quality products are designed and manufactured by Agilent, and are in alignment and compliance with national, regional and global regulations, our quality management system framework, company policies and business objectives.

• Develop and implement programs and processes to ensure that Agilent products are safe, legal, and meet or exceed customer expectations for regulatory compliance.

• Ensure quality management system (QMS) procedures are accurate and current.

• Provides expertise in translating regulatory requirements into practical, workable plans.

• Lead, drive, and deliver expected results according to budget, deliver on milestones, and participate in scoping project change requests and new projects.

• Oversee and direct quality and/or regulatory activities and executes key strategic programs within assigned area of responsibility.

• Prioritize resources and communicate resources needs, including presenting and submitting business cases when additional resources are needed.

• Work across Agilent divisions to provide CDx input into Agilent global processes and procedures.

• Participate in and contribute to internal and external quality audits, including hosting audits/auditors when needed.

• Provide input into risk management, human factors engineering, and drive quality initiatives and process efficiencies.

• Work with the Design Assurance team for CDx and liaise with Pathology Design Assurance team to identify areas of improvement and establish standardized best practices and processes.

• Manage performance of organization members, set staff objectives, and development initiatives.

• Develop and ensure a culture of success through collaboration with the team members and across development teams.

• Provide expertise, guidance and training within area of responsibility to the organization.

• Participate in product investigations, as needed.

• Act as a change agent to help establish a customer-centered culture.

• Exemplify Agilent’s values.  

Qualifications

• Education: Bachelor’s or Master’s Degree or equivalent plus directly relevant experience.

• Experience: Minimum of 3 years’ experience formally or informally leading people, projects and/or programs.

• Well-versed in Quality System Standards (ISO13485, FDA CFR 21 820, IVDR) and IVD/Medical Devices regulations in EU and USA

• Requires basic management skills and ability to design and execute processes

• Demonstration of excellent communication and teamwork skills

• Strong analytical and problem-solving skills with focus on finding the right solutions in compliance with regulations

• Ability to work independently with speed and focus Work experience in IVD/Medical Devices or pharmaceutical (regulated industry) highly desired

Additional Details

Travel Required:

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