Responsible for executing, adjusting, and providing technical support to manufacturing processes/equipment, ensuring compliance with quality, safety, and efficiency standards in a regulated environment. Actively participates in problem-solving, implementing improvements, and validating processes.
Requirements
- Advanced studies in engineering, mechanics, or related fields.
- Minimum of 4 years of manufacturing experience, with at least 2 years in a regulated industry (preferably medical).
- Intermediate knowledge of ISO 13485 and FDA regulations.
- Ability to interpret technical drawings and instructions in English (minimum B2 level).
- Experience leading validations, NCs, and CAPAs.
- Writing production documents such as Work Instructions (preferred).
Key Competencies:
- Attention to detail
- Adaptability
- Reliability and commitment
- Results and quality-oriented
- Teamwork and effective communication