Quality Engineer

KITE QE_1707406404
  • €75000 - €76000 per anuum
  • Hoofddorp, North Holland
  • Contract

Job Title: Quality Engineer

Location: Hoofddorp, NL - hybrid (2 days on-site)

Contract: 6 months

Hours: 40H P/W

Salary: 76000 EUR Brutto annual

Please note you must be able to work in The Netherlands without restriction or sponsorship to be eligible for this role. If you are interested in finding out more about this role or others, please contact Manpreet Bhullar at mbhullar@i-pharmconsulting.com or call UK: +44 (0)20 7551 0802 / NL: +31 20 809 0665.

i-pharm consulting is working with a global biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. We are seeking a highly motivated individual to join their team in Hoofddorp, NL as a Quality Engineer.

The Quality Engineer will support the team in the several MES projects in the role:

  • MES qualification/validation specialist (quality oversight role - supporting the current team of Quality Engineer professionals)

Specific Job Responsibilities:

  • Support the development of KPIs across the organization to drive improvement initiatives
  • Develops strategies to implement changes to processes.
  • Develops working engineering knowledge of products and contract
  • Contributes to organization processes across functions and interacts effectively with the other team members.
  • With guidance, prioritizes own work to ensure conformance to departmental goals.
  • Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
  • Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).
  • Develops solutions to more complex problems and identifies deviations from accepted practice and evaluates impact assessment as required.
  • Works directly with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
  • May assist with compliance audits as required.
  • Normally receives no instruction on routine work, general instructions on new assignments.

Knowledge:

  • Demonstrates proficiency in application of QE principles, concepts, industry practices, and standards.
  • Demonstrates strong verbal, technical writing and interpersonal skills.
  • Demonstrates knowledge of Six Sigma, Define-Measure-Analyse-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical is beneficial.
  • Demonstrates proficiency in Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)) is beneficial
  • The candidate *must have* Werum PAS-X experience (preferably: Werum PAS|X 3.1.8 version 2.1.0).

Education:

  • Minimum Education Level attained - BSc

Language Requirements:

  • English Speakers (minimum)

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