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:
Bachelor's or Master's Degree or equivalent plus directly relevant experience.2+ years' experience leading people, projects and/or programs in Quality Demonstrated experience with Quality System Standards (ISO13485, FDA CFR 21 820, IVDR) and IVD/Medical Devices regulations in EU and USAStrong analytical and problem-solving skills with focus on finding the right solutions in compliance with regulations Work experience in IVD/Medical Devices or pharmaceutical (regulated industry) highly desired
Additional Details:
This job has a full time weekly schedule. Applications for this job will be accepted until at least September 15, 2026 or until the job is no longer posted. The full-time equivalent pay range for this position is $136,618.00 - $213,465.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: https://careers.agilent.com/locationsAgilent Technologies, Inc. is an Equal Employment Opportunity and merit-based employer that values individuals of all backgrounds at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. Agilent Technologies, Inc., is committed to creating and maintaining an inclusive in the workplace where everyone is welcome, and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email job_posting@agilent.com or contact +1-262-754-5030. For more information about equal employment opportunity protections, please visit www.agilent.com/en/accessibility.Travel Required: Occasional
Shift: DayDuration: No End Date
Job Function: Quality/Regulatory
Summary
Location: US-CA-Carpinteria
Type: Full time
