Agilent Technologies
CDx Design Quality Senior Manager
US-CA-Carpinteria · Senior · Full-time
Sponsorship not specified$137k-$213kDetected 1 day ago
AccessibilityFDA RegulatoryMedical DevicesLeadershipCommunicationCollaborationProblem SolvingMentoringPublic Speaking
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odds of building a lasting career here
58Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role78
Entry-level history0
PERM / green-card track0
Lottery odds (Level IV)94
Fits your clock70
Sponsors, but it's cap-subject — you still face the weighted lottery (~61% per draw at Level IV). Good if you win; have a cap-exempt backup on your list.
Lottery odds assume a STEM candidate.
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from this employer's Department of Labor filings
Green-card filing pattern in this occupation
Context, not a finding about this posting: of this employer's 8 green-card filings in this occupation, 100% were for a worker who already held the job.
Files H-1B transfers
1 transfer filing in the last year, covering 1 worker. Median labor-condition decision: 8 days. An employer that already files transfers is one that can take over an existing H-1B.
Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.
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About the role
- Providing quality leadership and oversight for CDx development projects, including the timely resolution of quality-related issues.
- 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.
Responsibilities
- Ensuring effective implementation and execution of design controls, risk management, and quality processes throughout product development.
- 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.
- Lead, drive, and deliver expected results according to budget, deliver on milestones, and participate in scoping project change requests and new projects.
Requirements
- Approving quality documents, procedures, and records, as required.
- Education: Bachelor's or Master's Degree or equivalent plus directly relevant experience.
- 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
- This job has a full time weekly schedule. Applications for this job will be accepted until at least September 11, 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/locations
- Agilent 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.
Compensation
- The full-time equivalent pay range for this position is $136,618.00 - $213,465.00/yr plus eligibility for bonus, stock and benefits.
Company info
- 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.
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