Beschreibung
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.
Qualifications:
- 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