Product Quality Specialist

2 months ago

Glostrup, Glostrup Kommune, Denmark Agilent Technologies Full time

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.

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.
  • An opportunity to make a significant impact and develop your skills in a world-class company that takes pride in developing innovative solutions for pathology labs worldwide to improve cancer diagnostics.
  • A role among passionate colleagues, in a growth-oriented and inclusive environment. You will become part of a caring and fast-paced environment, built on integrity, sharing, and trust.
  • Core global benefits, including the Agilent Result Bonus and Stock Purchase Plan.

This position will report to the Manager for the Product Quality and Post Market Surveillance department.

#LI-NE1

Agilent Technologies Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other protected categories under all applicable laws.

Option to Work Remote
Yes

Travel Required
Occasional

Schedule
Schedule:Full time

Shift
Day

Duration
No End Date

Job Function
Quality/Regulatory
Location: Denmark-Glostrup

  • Product Development Specialist

    1 week ago

    Glostrup, Glostrup Kommune, Denmark Agilent Full time

    About AgilentAgilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek, so they can do what they do best: improve the world...

  • Advanced Technical Support Specialist

    1 week ago

    Glostrup, Glostrup Kommune, Denmark Agilent Full time

    About the RoleAgilent is seeking a highly skilled Technical Excellence Specialist to join our Dako Academy/Technical Support team in Glostrup. As a key member of our team, you will be responsible for providing advanced technical support to our field-based application specialist colleagues and customers.Key ResponsibilitiesTroubleshoot complex technical...

  • Ceramic Production Specialist

    6 days ago

    Glostrup, Glostrup Kommune, Denmark mk-ceramics Full time

    About MK STUDIOAt MK STUDIO, we are a creative hub dedicated to producing high-quality porcelain items that adorn esteemed establishments worldwide. Our work is a fusion of traditional craftsmanship and modern techniques, combining 3D modeling, 3D printing, and laser engraving to bring our unique designs to life.Job SummaryWe are seeking an energetic and...

  • Technical Excellence Specialist

    1 week ago

    Glostrup, Glostrup Kommune, Denmark Agilent Full time

    About the RoleAgilent is seeking a highly skilled Technical Excellence Specialist to join our Dako Academy/Technical Support team in Glostrup. As a key member of our team, you will be responsible for providing advanced technical support to our field-based application specialist colleagues and customers.Key ResponsibilitiesTroubleshoot complex technical...

  • Senior Technical Support Specialist

    1 week ago

    Glostrup, Glostrup Kommune, Denmark Agilent Full time

    About the RoleAgilent is seeking a highly skilled Technical Excellence Specialist to join our Dako Academy/Technical Support team in Glostrup. As a key member of our team, you will be responsible for providing advanced technical support to our field-based application specialist colleagues and customers.Key ResponsibilitiesTroubleshoot complex technical...

  • R&D Software Design Control Specialist

    1 week ago

    Glostrup, Glostrup Kommune, Denmark Agilent Full time

    About AgilentAgilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek, so they can do what they do best: improve the world...

  • Regulatory Affairs Specialist, IVDR

    20 hours ago

    Glostrup, Glostrup Kommune, Denmark Agilent Full time

    About the RoleAgilent is seeking a highly motivated Regulatory Affairs Specialist to play a key role in coordinating and tracking International submissions, product change notifications, product release and licensing requirements, and registration of IVD products for Agilent's extensive IVD portfolio.Key ResponsibilitiesSupport IVDR regulatory activities,...

  • Regulatory Affairs Specialist, IVDR

    20 hours ago

    Glostrup, Glostrup Kommune, Denmark Agilent Full time

    About the RoleAgilent is seeking a highly motivated Regulatory Affairs Specialist to play a key role in coordinating and tracking International submissions, product change notifications, product release and licensing requirements, and registration of IVD products for Agilent's extensive IVD portfolio.Key ResponsibilitiesSupport IVDR regulatory activities,...

  • Order Management Specialist

    7 days ago

    Glostrup, Glostrup Kommune, Denmark Agilent Technologies Full time

    About Agilent TechnologiesAgilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. We enable customers to gain the answers and insights they seek -- so they can do what they do best: improve the...

  • Software/Hardware Design Control Specialist

    1 week ago

    Glostrup, Glostrup Kommune, Denmark Agilent Technologies Full time

    Job OverviewAgilent Technologies is seeking a highly skilled Design Control Specialist to join our team. As a key member of our organization, you will be responsible for planning, specifying, developing, testing, releasing, and documenting IT Accessories used with our medical devices and IVD products.Key ResponsibilitiesDesign and Development: Initiate and...

  • Ceramic production worker

    1 month ago

    Glostrup, Glostrup Kommune, Denmark mk-ceramics Full time

    This offer is only for individuals currently residing in Denmark with a valid work permit. Are you passionate about the art of ceramics and porcelain craftsmanship? MK STUDIO, a renowned ceramic workshop based in Glostrup is seeking a skilled and independent Ceramic Production Manager to join our team. If you have a keen eye for precision, a love for detail,...

  • Field Technical Specialist

    1 week ago

    Glostrup, Glostrup Kommune, Denmark Abbott Full time

    About AbbottAbbott is a global healthcare company dedicated to improving lives through the development of innovative products and technologies that span the breadth of healthcare. Our mission is to empower individuals to live their best possible lives through the power of health.The RoleWe are seeking a highly skilled Field Technical Specialist to join our...

  • EMEA Marketing Communications Specialist

    1 month ago

    Glostrup, Glostrup Kommune, Denmark Agilent Technologies Full time

    France-OlympeFrance-Remote Location-Les UlisItaly-Remote Location-Torino​Denmark-Remote Location-GlostrupEMEA Marketing Communications SpecialistJob DescriptionAgilent encourages and supports discoveries that advance the quality of life. We provide life science, diagnostic, and applied market laboratories worldwide with instruments, services, consumables,...

  • Senior Supplier Quality Engineer

    1 week ago

    Glostrup, Glostrup Kommune, Denmark Agilent Technologies Full time

    About the RoleAgilent Technologies is seeking a highly skilled Senior Supplier Quality Engineer to join our team. As a key member of our quality assurance team, you will be responsible for ensuring compliance with various regulations and standards, leading supplier quality compliance projects, and developing partner quality agreements.Key...

  • Field Technical Specialist

    1 week ago

    Glostrup, Glostrup Kommune, Denmark Abbott Laboratories Full time

    About Abbott LaboratoriesAbbott Laboratories is a global healthcare company dedicated to improving lives through the development of innovative products and technologies that span the breadth of healthcare. Our mission is to provide life-changing technologies that promote good health, nourish the body, and bring breakthroughs to manage health.We are committed...

  • Global Product Manager, Pathology Solutions

    1 week ago

    Glostrup, Glostrup Kommune, Denmark Agilent Technologies Full time

    Job OverviewAgilent Technologies is seeking a highly skilled Global Product Manager to join our team in the Pathology Division. As a key member of our global Product Management team, you will be responsible for developing and executing product portfolio strategies to drive improved sales, market share, and profitability.Key ResponsibilitiesDevelop and...

  • Product Development Lead

    1 week ago

    Glostrup, Glostrup Kommune, Denmark Agilent Full time

    About the RoleWe are seeking a highly skilled R&D Scientist to join our team as a Design Responsible for a product line. As a key member of our team, you will be responsible for design control activities, new product development, and executing tasks related to sustaining and maintaining our risk files.Key ResponsibilitiesPlan, generate, and update Design...

  • Spatial Suite Support Specialist

    1 week ago

    Glostrup, Glostrup Kommune, Denmark Sweco Danmark AS Full time

    About the RoleSpatial Suite Support Specialist at Sweco Danmark A/S is a key position in our Customer Success team. As a central figure in creating good customer relationships, you will be the face of our company and a vital link between our customers and the rest of the organization.Key ResponsibilitiesIdentify and troubleshoot issues in our own...

  • R&D Scientist

    1 week ago

    Glostrup, Glostrup Kommune, Denmark Agilent Full time

    About the RoleWe are seeking a highly motivated and experienced R&D Scientist to take on the role of Design Responsible for a product line at Agilent. As a key member of our team, you will be responsible for leading design control activities, new product development, and executing tasks related to sustaining and maintaining our risk files.Key...

  • IVDR Regulatory Expert

    1 week ago

    Glostrup, Glostrup Kommune, Denmark Agilent Full time

    About AgilentAgilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Our mission is to enable customers to gain the answers and insights they seek, so they can improve the world around us.About...