Beschreibung
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&R methodology, as defined by GAMP, AAMI, ASQ, DePuy or Legacy. The person must be analytical, thorough, accuraand proficient in the use of computers. Manufacturing processing background is required, as the special processes are generally not verifiable; 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 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.