Senior Product Quality Engineer

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.

• 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.

• 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