Manufacturing Quality Assurance Specialist

4 weeks ago

Glostrup, Glostrup Kommune, Denmark Agilent Full time

About the Role

Agilent is seeking a skilled Manufacturing Quality Assurance Specialist to join our team. As a key member of our QA department, you will be responsible for ensuring the quality and compliance of our manufacturing processes.

Key Responsibilities:

  • Apply advanced Quality Engineering/Scientific Method techniques and principles to daily tasks and activities.
  • Make decisions on quality & compliance issues with little guidance.
  • Ensure site compliance with Regulations, ISO standards, local standard operating procedures (SOPs).
  • Serve as the Subject Matter Expert (SME) of the multiple quality processes.
  • Lead improvement activities/improvement of standards within quality management system.
  • Support, review & approve complex cross-functional investigations & root-cause analysis.
  • Facilitate sharing of regulatory & compliance expectations.
  • Facilitate presentation & support for audits & inspections.
  • Eliminates non-value-added practices.

Requirements:

  • Bachelor's or master's degree in a Quantitative/Scientific/Technical discipline.
  • +2 years of work experience in the medical device or pharmaceutical industry
  • Preferably experience working with In Vitro Diagnostic and/or Medical Devices
  • Strong knowledge and understanding of standards and regulations: ISO 13485, Regulation (EU) 2017/746, ISO 14971:2019 and regulations covered under MDSAP
  • LEAN mindset.
  • Leading and/or contributing to root cause investigations using various problem-solving techniques and tools and assessing the effectiveness of corrective actions.
  • Strong verbal and written communication skills
  • Results oriented and willing to take accountability.
  • Thrive working cross-functionally with people at all levels of the organization
  • Flexible, systematic, and engaged team player
  • Full fluency to read/write/speak in English on 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.

Please note Job level will be adjusted according to relevant experience and qualifications.

This job has a full time weekly schedule.

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:

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