Maintenance Engineer
Job Title: Freelance Maintenance Engineer - Medical Devices
Location: On-site, Poland
Contract Type: Freelance
Start Date: Immediate / Negotiable
Duration: Initial 12 months, with potential for extension
Overview:
We are recruiting a Freelance Maintenance Engineer to support on-site operations at a medical device manufacturing facility in Poland. This role is ideal for a technically skilled professional with a strong understanding of regulated environments and hands-on experience in maintaining complex equipment used in medical device production.
Key Responsibilities:
- Conduct preventive and corrective maintenance on manufacturing equipment used in medical device production.
- Diagnose and resolve mechanical, electrical, and automation issues to ensure minimal downtime.
- Ensure all maintenance activities comply with ISO 13485, EU MDR, and FDA regulations.
- Maintain accurate records of maintenance, calibration, and validation activities.
- Support equipment qualification and re qualification processes.
- Collaborate with cross-functional teams including Engineering, Quality, and Production.
- Participate in internal and external audits as required.
Candidate Requirements:
- Proven experience as a Maintenance Engineer in a medical device manufacturing environment.
- Strong knowledge of GMP standards and ISO 13485 compliance.
- Technical expertise in mechanical systems, PLCs, and automated production lines.
- Ability to read and interpret technical documentation and engineering drawings.
- Fluent in English; Polish language skills are a plus.
- Must have the legal right to work in Poland (EU citizenship or valid work permit).
- Willingness to work full-time on-site for the duration of the contract.
Preferred Qualifications:
- Degree or vocational training in Mechanical, Electrical, or Bio-medical Engineering.
- Experience working in clean-room environments.
- Familiarity with CMMS systems and digital maintenance platforms.
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