Design Assurance Senior Specialist

Description

The Design Assurance (DA) / Quality Assurance Specialist will participate in product development, project reviews, and relevant project meetings and will ensure that high quality products are designed, engineered and manufactured by Agilent, in conformance with customer requirements, internal procedures and required standards and regulations.

The DA Specialist will represent QA on project teams for Companion Diagnostics (CDx). Duties include review and approval of design control documents and design changes, support Deviations, Nonconformances, and CAPA’s, and support change control management as a subject matter authority.

Frequent QA consultations are necessary as the project teams all proceed on a unique path through the development process.

Due to confidentiality agreements with the pharmaceutical partners, a sample project list is not included here.

Additional non-pharma sponsored duties may include product investigation support, internal and external audits (partner, regulatory) and to support, as needed, Regulatory Affairs functions in support of CDx projects and filings.

May initiate and support Quality Management Systems (QMS) improvements within area of responsibility. Provide expertise, guidance and training within area of responsibility to the organization.

Responds to customers and / or authorities requests / inquiries dealing with regulations and product compliance.

Consults to ensure that high quality products are designed and manufactured by Agilent in conformance with customer requirements and required standards and regulations.

Develops and implements quality initiatives to improve the organization’s core business processes and to influence maintaining a customer-centered organization.

Support and maintain Quality Management System (such as ISO13485) and support Quality Management System (QMS) improvement projects.

May provide expertise, training and / or consulting in Quality processes and methods to build and maintain a customer-oriented quality culture.

May direct the work of third parties such as vendors, product partners, etc. to meet contract specified deliverables, performance or business objectives.

Examples of non-Pharma sponsored projects include :

Product Care Reviews

Development Partnership Preparation

Point of contact for the procurement process (CDx related) which includes supplier / item risk assessment for New Supplier relationships.

Audit Support : Pharma / Regulatory Agency / Internal Audit

Design Change : Change Control Board

Risk Management Review Board

Product Development and Design Control and related procedure(s), Updates / Reviews / Revisions

Qualifications

Bachelor's or Master's Degree or equivalent

Post-graduate, certification and / or license may be required

4+ years relevant experience for entry into this level

Proficient in Quality System Standards (ISO13485, FDA CFR 21 820) and IVD / Medical Devices legislation in EU and USA

Business oriented and a desire to work in a dynamic and adaptable environment

Strong analytical skills with focus on finding the right solutions in compliance with the regulations

An effective communicator at all levels, both internally and externally

Team player with the ability to make independent decisions within the framework and guidelines of the organization

LI-DT1

The US pay range for this full-time position is $85, - $158,, plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location.

The range displayed on each job posting reflects the minimum and maximum new hire pay for the position across the relevant US locations.

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. Additional details are available at :

Agilent Technologies, Inc. is an Equal Employment Opportunity and Affirmative Action employer. We value diversity 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 diversity in the workplace 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 or contact +1-262-754-5030.

For more information about equal employment opportunity protections, please visit

Pay Range

$85,$158,

The salary range for this position may differ based on your actual work location.

Eligible for Company Car

Benefits in Brief

Option to Work Remote

Travel Required

10% of the Time

Schedule

Schedule : Full time

Shift

Duration

No End Date

Job Function

Quality / Regulatory