Calibration Engineer Job in Switzerland

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Calibration Engineer Job Description

• With oversight from the core team leads, determine and report on the state of compliance of the quality system versus regulatory standards (ISO, FDA, etc.).
• Audit sites’ calibration, MSA, Gage R&R.
• Plan to the standards and report out on findings (both current state and retrospectively).
• Make recommendations to achieve compliance where shortfalls are found.
• Provide Audit reports as directed.
• Consult and guide all employees and manages regarding calibration and measurement equipment and operational practices.
• Training of all involved employees along the Calibration, MSA, Gage R&R processes.
• Bringing in of improvement proposals, which increase the productivity quality of measurement equipment and operational practices.

Calibration Engineer Job Requirements

• Engineering Degree (Mechanical)
• Measurement Equipment Specialist
• Minimum of 10 years quality / compliance experience in the medical device or pharmaceutical industries
• Minimum 10 years of experience as calibration engineer in medical device metal industry
• Compliance experience in the medical device
• 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 spreadsheet software (Excel, Access, Q-DAS, SAP etc.
• Familiarity and interaction experience with regulatory auditing bodies preferred
• Manufacturing processing background is required, as the special processes are generally not verifiable; thus, the validation requirement
• Documented training in FDA QSR, ISO 13485 / 9001 required
• Proficient in the use of spreadsheet software (Access / Excel etc.)
• Be able to work with various databases to extract and report out required information (Excel, Access, Q-DAS, SAP etc.)
• Thorough understanding of GMP and GCP (Good Clinical Practices) guidelines
• Know and follow the guidelines regarding the code of conduct, ethics and compliance programs and other relevant regulations at all times
• Should be versed in the calibration, MSA and Gage R&R methodology, as defined by GAMP, AAMI, ASQ,…
• Proficient in the related ISO 13485 standards sections and related 21 CFR 820 regulatory subchapters
• Excellent organizational skills, readiness to take on responsibility, reliable, proactive and self-driven, very good communicational skills, customer oriented
• Be able to manage effectively multiple priorities and tasks
• Be willing and able to travel domestically to other EU sites as required
• The person must be analytical, thorough, accurate and proficient in the use of computers
• Able to travel, to perform internal audits and be able to work independently with minimal supervision
• Fluently German / English spoken and written

Calibration Engineer Application Information

Do you want to apply for this position? Please send us your cv and cover letter below. Do you have additional questions? Please mail us at [email protected] or give us a call at 0032 9-324 70 80.

Calibration Engineer Summary

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