Product Quality Specialist

Agilent Technologies

Glostrup, Denmark

Job Description

The product quality specialist 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 design transfer and risk management updates for the relevant product platforms.

The daily tasks will for instance include driving product quality investigations resulting from complaints 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 and describing complex processes, problems and quality/compliance issues in a clear and succinct manner that will ensure clear and compelling CAPAs and thorough and robust root cause analysis.

This will be done in close collaboration with other quality functions across the company and the post market surveillance specialists.

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

The Product Quality Assurance Associate is dedicated to ensuring the highest quality experiences for our patients and customers. This position is responsible for driving and supporting quality assurance activities related to lifecycle management, including Product Investigations, Post Market Surveillance, Vigilance, and assisting in Product Complaints technical investigations for the relevant product platforms.

Key responsibilities

Drive product quality investigations resulting from complaints and support root cause investigations concerning product and manufacturing issues.
Review and align CAPAs (Corrective Action / Preventive Action) according to corporate procedures and guidelines across the division.
Understand complex processes, problems, and quality/compliance issues, and effectively describe them in a clear and concise manner suitable for audit and inspection settings.
Collaborate closely with other quality functions and post-market surveillance specialists within the team.
Support R&D in ensuring compliance when making minor design changes and updates to our product portfolio.
Apply advanced Quality Assurance and Scientific Method techniques and principles to daily tasks and activities.
Apply relevant regulations, standards, GxP requirements, and industry best practices to assignments.
Plan and conduct projects and activities with moderate to high technical responsibility, complexity, and strategic input.
Act as a subject matter expert in routine quality assurance and scientific matters as applicable.
Develop and drive key strategic quality assurance and scientific initiatives throughout the organization.
Collaborate with other quality partners to identify required quality assurance skills and competencies to execute strategic visions or plans.
Involve in quality systems initiatives as a primary or additional assignment, potentially impacting business improvement, quality systems, and lifecycle management.
Perform other duties as assigned.

Qualifications

Bachelor’s degree in engineering, science, or related technical field from an accredited institution is required. An advanced degree is preferred.
A minimum of 5 years of work experience is expected, preferably in a regulated industry (medical device, biopharmaceutical, or pharmaceutical).
Experience working with ISO 13485, FDA CFR 21 Part 820, and ISO 14971.
Experience leading and/or contributing to root cause investigations using various problem-solving techniques and tools and assessing the effectiveness of corrective actions.
Demonstrated proficiency in driving root cause analysis and CAPA investigations.
Proficiency in applying established tools and methods (e.g., 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.
Process and detail-oriented, proactive team player capable of working cross-functionally with people at all organizational levels.
Full fluency in English at a business level.

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