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Calibration Engineer - Subject Matter Expert
Eingestellt von Harvey Nash IT Recruitment Switzerland
Gesuchte Skills: Engineer, Sap
Projektbeschreibung
For a project in Solothurn, we are looking for a CALIBRATION ENGINEER - SUBJECT MATTER EXPERT
Knowledge & Skills:
- The resource should be versed in the calibration, MSA and Gage R thus, the validation requirement.
- The resource must be proficient in the related ISO 13485 standards sections and related 21 CFR 820 regulatory subchapters.
- The resource should have the ability to travel, to perform internal audits and be able to work independently - with minimal supervision
Required degree/certificates:
- Degreed Engineer (Mechanical) Measurement Equipment Specialist
Specific technical skills (please detail):
- Be able to work with various databases to extract and report out required information (Excel, Access, Q-DAS, SAP etc.).
Specific knowledge for the role:
- Thorough understanding of GMP and GCP (Good Clinical Practices) guidelines.
Languages:
- Fluently German/English spoken and written
Competencies:
- Excellent organizational skills, readiness to take on responsibility, reliable, proactive & self-driven, very good communicational skills and customer oriented
- Be able to manage effectively multiple priorities and tasks
- Good communication skill
- Know and follow the guidelines regarding the code of conduct, ethics and compliance programs and other relevant regulations at all times
- Excellent organizational skills, readiness to take on responsibility, reliable, proactive & self-driven, very good communicational skills and customer oriented
- Team player
Experience:
- Minimum of 10 years quality/compliance experience in the medical device or pharmaceutical industries.
- Prior experience in medical device/pharmaceutical remediation preferred.
- Familiarity and interaction experience with regulatory auditing bodies preferred.
- Documented training in FDA QSR, ISO 13485/9001 required.
- Proficient in the use of spread sheet software (Excel, Access, Q-DAS, SAP etc.)
- FDA QSR, ISO 13485
Are you interested in this position? We are looking forward to receive your application. Many thanks.
Knowledge & Skills:
- The resource should be versed in the calibration, MSA and Gage R thus, the validation requirement.
- The resource must be proficient in the related ISO 13485 standards sections and related 21 CFR 820 regulatory subchapters.
- The resource should have the ability to travel, to perform internal audits and be able to work independently - with minimal supervision
Required degree/certificates:
- Degreed Engineer (Mechanical) Measurement Equipment Specialist
Specific technical skills (please detail):
- Be able to work with various databases to extract and report out required information (Excel, Access, Q-DAS, SAP etc.).
Specific knowledge for the role:
- Thorough understanding of GMP and GCP (Good Clinical Practices) guidelines.
Languages:
- Fluently German/English spoken and written
Competencies:
- Excellent organizational skills, readiness to take on responsibility, reliable, proactive & self-driven, very good communicational skills and customer oriented
- Be able to manage effectively multiple priorities and tasks
- Good communication skill
- Know and follow the guidelines regarding the code of conduct, ethics and compliance programs and other relevant regulations at all times
- Excellent organizational skills, readiness to take on responsibility, reliable, proactive & self-driven, very good communicational skills and customer oriented
- Team player
Experience:
- Minimum of 10 years quality/compliance experience in the medical device or pharmaceutical industries.
- Prior experience in medical device/pharmaceutical remediation preferred.
- Familiarity and interaction experience with regulatory auditing bodies preferred.
- Documented training in FDA QSR, ISO 13485/9001 required.
- Proficient in the use of spread sheet software (Excel, Access, Q-DAS, SAP etc.)
- FDA QSR, ISO 13485
Are you interested in this position? We are looking forward to receive your application. Many thanks.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
SAP Entwicklung, Ingenieurwesen/Technik