MSA Validation Specialist (m/f/d)

Krakow  ‐ Onsite


Measurement and Metrology Calibration Auditing Business Process Improvement Data Analysis Strategic Management Corrective and Preventive Action (CAPA) Regulatory Compliance Computer Programming Consulting Health Technology Project Management Negotiation Pricing Strategies Purchasing Process Statistics Model Validation Coaching and Mentoring Medical Material


Dear Madam or Sir,

for my client in Kraków I am currently looking for a MSA Validation Specialist (m/f/d).
  • Start: 11.04.24
  • Duration: 2,5 Monate
  • Location: Kraków, Krakau
  • Project: Support Metrology/ Calibration
  • Travel expenses from Germany will be covered
  • German terms contract

Key Responsibilities:
  • Calibration and Validation: Conduct calibration and validation of test and data analysis equipment and systems. Assist in equipment selection, specification, and negotiation for competitive pricing.
  • Strategic Development and Project Coordination: Responsible for the development of measurement and test strategies, providing support to local process owners and engineering groups, coaching and advising all technical groups on metrology-related topics.
  • Technical Analyses: Perform technical analyses of metrology problems or requirements, identifying and implementing new advanced measurement and test solutions and technologies.
  • Continuous Improvement: Develop work methods for continuous improvement and management of metrology processes.
  • Regulatory Compliance: Apply in-depth knowledge and understanding of US and international medical device regulations, independently implementing applicable quality concepts (e.g., CAPA, audits, statistics).
  • Regulatory Liaison: Act as the main contact for regulatory authorities (FDA, TÜV, etc.) in routine and audits.

  • Professional mastery in metrology, inspection means management, and validation, with a focus on MSA, Equipment Qualification, and URS.
  • Proficient in using and programming IMTE (control, test, and inspection equipment).
  • Applied statistical knowledge to enhance analytical capabilities.
  • Fluent in English (C1).
  • College degree or equivalent.
  • Minimum of 4 years of relevant experience, demonstrating the ability to apply principles, resolve technical issues, and make evaluative judgments based on factual information.

Additional Notes:
  • MSA measurement method validation
  • Validation (senior technician)
  • Experience in measurement technology (validation, optimization of programs, process comparison)
  • GR&R
  • Roll out processes locally in such a way that corporate regulations are also taken into account
  • Technical profile
  • Very good knowledge of English
  • Experience with setting up processes
  • Experience in medical technology // (if no Meddev experience then at least experience in metallic material processing)
  • Experience in calibration
    • Management of all measuring equipment
    • Provision of measuring equipment (purchasing)
    • Calibration due dates
    • Check all testing processes
    • Obligation to provide proof of calibration certificates

If you are interested, please send me your current CV with the earliest possible start date and your desired hurly rate. I will get back to you after sighting.

I look forward to your feedback and thank you in advance.

Viele Grüße
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