Senior Product Quality Engineer

Job Description

The Senior Product Quality Engineer shares a passion for ensuring the highest quality experiences for our patients and customers. This position will be responsible for driving and supporting the quality engineering activities pertaining to lifecycle management including Product Investigations, Post Market Surveillance, Vigilance and assist in Product Complaints technical investigations for the relevant product platforms.

Key daily tasks will include driving product quality investigations resulting from complaints, post market surveillance reporting, product quality reviews, incident trending etc. as well as supporting/driving root cause investigations concerning product and manufacturing issues. This entails reviewing and aligning CAPAs (corrective action / preventive action) according to procedures and guidelines across the division.  Other tasks constitute understanding complex processes, problems and quality/compliance issues in a clear and succinct manner that will ensure clear and compelling product investigations/CAPAs and thorough and robust root cause analysis.

This will be done in close collaboration with other quality and support functions such as field actions, vigilance and the post market surveillance team.

It is also expected that the position supports R&D in ensuring compliance when making minor design changes and updates to our product portfolio.

Under limited supervision/general direction and in accordance with all applicable federal, state and local laws/regulations and corporate procedures and guidelines, this position:

• Applies advanced Quality Engineering/Scientific Method techniques and principles to daily tasks and activities.
• Applies relevant regulations, standards, GxP requirements, and industry best practices to assignments.
• Plans and conducts projects and activities with moderate to high technical responsibility, complexity, and strategic input.
• Acts as a subject matter expert in routine quality engineering and scientific matters.
• Develops and drives key strategic quality engineering/scientific initiatives throughout the organization.
• Supports the execution of strategic vision or plan by collaborating with other quality partners to identify required quality engineering skills and competencies.
• The quality engineer will also be involved with quality systems initiatives as a primary assignment or additional assignment. Generally, the projects will involve potentially greater business impact in the following areas:
  • Business improvement
  • Quality systems
  • Lifecycle management
• Performs other duties assigned as needed.

You will report to the manager for the Product Quality and Post Market Surveillance department located in Denmark. Please be aware that availability from 5am PST is expected to accommodate a team spread over three different time zones in Denmark and the US.

We Offer:

• An inspiring and social environment with around 40 skilled colleagues in the QA department providing QA support within development, manufacturing and sustain activities. 
• A great opportunity for you to make a significant impact and develop your skills in a world-class company that takes pride in developing new innovative solutions for the pathology labs around the world to improve cancer diagnostics. 
• A role among passionate colleagues, in a growth orientated and inclusive environment. You will become part of a caring and fast paced environment, built on integrity, sharing and trust.
• Agilent offers core global benefits to all staff including Agilent Result Bonus and Stock Purchase Plan.

Qualifications

• Bachelor’s degree in engineering. A relevant advanced degree is preferred.
• A total of 8+ years of work experience is expected. Experience in a regulated industry (medical device, biopharmaceutical, or pharmaceutical) is preferred.
• Experience working with ISO 13485, FDA CFR 21 Part 820 and ISO 14971.
• Understands and applies risk determinations from FMEAs and other Risk documents.
• Leading and/or contributing to root cause investigations using various problem-solving techniques and tools and assessing the effectiveness of corrective actions.
• Experienced in driving and/or owning root cause analysis and Corrective Action / Preventive Action (CAPA), Non-Conformance, or Supplier Corrective Action investigations to timely closure.
• Demonstrates a high level of proficiency in applying established tools and methods (for example, Six Sigma, Lean) to identify and realize new process introductions, as well as process and business improvements.
• Ability to review and approve complex CAPA issues to assure successful audit review.
• On a personal level, you are process and detail oriented as well as a proactive team player who’s capable of working cross-functionally with people at all levels of the organization.
• Full fluency to read/write/speak in English on a business level.

Additional Details

This job has a full time weekly schedule. It includes the option to work remotely. Applications for this job will be accepted until at least March 17, 2025 or until the job is no longer posted.

The full-time equivalent pay range for this position is $111,840.00 - $209,700.00/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 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 [email protected] or contact +1-262-754-5030. For more information about equal employment opportunity protections, please visit www.agilent.com/en/accessibility.Travel Required: OccasionalShift: DayDuration: No End DateJob Function: Quality/Regulatory