Quality Assurance Engineer – Agilent – Middelburg

Agilent

Description

Agilent 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 around us. Information about Agilent is available at

The Chemistries & Supplies Division (CSD) develops, manufactures, procures, and supports state-of-the-art consumables including liquid- and gas-phase separation columns, sample preparation, performance chemicals, glycobiology and bioanalytical proteins, and a full portfolio of supplies for life science instrumentation.

Our Global Quality & Regulatory Affairs (GQRA) organization owns and maintains a robust ISO 9001 Quality Management System for use by all functions in the division. The organization is also responsible for maintaining hardware and chemical/biological regulatory compliance, where applicable. Our Product Support organization assists customer and field service as well as providing customer feedback insights to the division. Our organization leads and supports continuous improvements to ensure compliance and efficiency.

As a Quality Assurance Engineer, you will act as the Quality Management System Lead for the Middelburg site, reporting into the GQRA organization while supporting CSD. Middelburg is a manufacturing site for Consumables and Supplies related to gas and liquid chromatography.

All Quality Assurance Engineers are responsible for:

  • Provide trusted quality insights to cross-functional internal and external customers.
  • Support organizational compliance for our Quality Management System (process and training management, performance dashboard preparation, audit readiness and support, customer agreements) and assist with continuous improvements.
  • Represent Quality Assurance on cross-functional teams for the Product Lifecycle and Design Traceability Matrix.
  • Partner with Regulatory Affairs to understand and implement requirements such as Safety, Electromagnetic Compatibility (EMC), Restriction of Hazardous Substances (RoHS), REACH, Environmental Health and Safety (EHS), Safety Data Sheet (SDS), etc.
  • Partner with Product Support to gather and analyze customer feedback to identify and implement corrective actions, corrections, and continuous improvement.
  • Additional responsibilities may include:

  • Own and improve the division and local ISO 9001 Quality Management Systems including alignment to Agilent and group level QMS.
  • Create and conduct quality training with proper effectiveness verification and traceability. Collaborating with cross-functional division and site leads to ensuring the organization is sufficiently trained.
  • Lead Corrective and Preventative Action (CAPA) program at the division and site level.
  • Prepare and communicate division and local quality performance dashboard including customer complaints (defects on arrival, warranty, product safety events, customer surveys, etc.), achievements and customer satisfiers, and proactive change notification.
  • Lead external (registrar and customer) and internal audits as well as regular site-evaluation assessments. Track audit findings and collaborate with site management to develop corrective action plans and drive to closure.
  • Upon request, manage customer quality and change control agreements, questionnaires, and Supplier Corrective Action Reports (SCAR). Lead customer communication to ensure quality and contractual compliance.
  • The position is based in Middelburg. Options to work on a hybrid model (3 days in the office, 2 days from home) or possible remote model (with requirement to be onsite at a regular frequency, , 1 day a week) may be discussed after initial training period onsite and depending on site business needs.

    Qualifications

  • University degree, or equivalent, in Chemistry, Life Sciences, Engineering, or related field.
  • Minimum 8 years’ experience with Quality Assurance, ISO Compliance, and/or Quality Management Systems.
  • Experience with ISO 9001:2015, or similar, required.
  • Familiarity with the Corrective and Preventive Action process (CAPA) required.
  • Analytical skills (Root Cause Analysis (RCA), Six Sigma, MSA, Failure Modes and Effects Analysis (FMEA)) knowledge preferred.
  • Experience and practical application of Continuous Improvement tools and mindset preferred.
  • Experience with Agile PLM a plus.
  • Effective communication skills and ability to work independently and collaborate with cross-functional and global teams.
  • Proficient in Microsoft Office Suite (Word, Excel, PowerPoint).
  • A strong customer focus is essential.
  • Experience and knowledge of chromatography is strongly preferred.
  • Proficient in understanding, speaking, and writing English and Dutch.
  • We offer:

  • An opportunity for you to make a significant impact in a world-class company and develop your skills
  • Career development opportunities in an international company
  • Competitive compensation and benefits package
  • Work-Life-Balance programs
  • Permanent contract in a fast-growing global company
  • Company pension scheme
  • Private health care
  • 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

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