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Process Improvement Specialist
2 mesi fa
Job Summary:
This position provides Quality Engineering support with the goal to continuously improve process/product quality and reliability.
Key Responsibilities:
- Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) activities.
- Support Kerr Italia Quality Engineer to provide technical support to manufacturing processes and process validation in the pursuit of improving material, product or process quality and reliability.
- Collaborate with cross-functional teams to identify and implement process improvements.
- Develop and maintain technical documentation, including procedures, work instructions, and reports.
- Conduct failure analysis and implement corrective actions to prevent recurrence.
- Ensure compliance with GMPs/ISO 13485 requirements.
- Develop and maintain knowledge of industry trends and best practices.
Requirements:
- Bachelor of Science degree (B.S.) in Engineering or equivalent plus at least 6 months or more quality engineering experience within the medical technology industry or equivalent, or equivalent combination of education and experience.
- Fluent in English and Italian.
- Solid understanding of ISO 13485/GMP requirements.
- Excellent prioritizing, organization, interpersonal, communication and analytical skills.
- Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
- Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
