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Subject Matter Expert (Technical Writer)
Eingestellt von MBA - Zurich
Gesuchte Skills: Support, Sap
Projektbeschreibung
Subject Matter Expert (Technical Writer):
Duties and Responsibilities:
- 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.).
- Support to generate the new Standard for process in EU.
- Generate Redline as per instructions.
- Generate SOP in accordance to the regulation.
- Generate DCR/DCO after training.
- Maintain and generate CAPA's file (not implement task and actions)
- With oversight from the Core Team Leads (CTL), generate reports, graphical analyses, and trend charting.
- Perform database analyses as directed by CTL (Pareto, trend charting, histogram, etc.)
- Be able to work with various databases to extract and report out required information (Excel, Access, Q-DAS SAP etc.)
- Demonstrated ability to produce accurate, timely and succinct reports and summaries.
- Be able to manage effectively multiple priorities and tasks.
- Work independently and in a team environment.
- Generate SOP as per regulation requested.
- Fluently German mother language/English spoken and written
- 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, customer oriented
- Team player
- Travel required form site to site (10 - 15%)
Experience:
- Minimum of 4 years experience as document writer or similar position.
- Proficiency with a variety of computer software applications in word processing,
Spreadsheets, database and presentation (MS Word, Excel, PowerPoint, etc.).
- Compliance experience in the medical device.
- Familiarity and interaction experience with regulatory auditing bodies preferred.
- Documented training in FDA QSR, ISO 13485/9001 required.
Start: ASAP or latest mid May
Duration: 6 - 9 months
Languages: German and EnglishMichael Bailey International is acting as an Employment Business in relation to this vacancy.
Duties and Responsibilities:
- 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.).
- Support to generate the new Standard for process in EU.
- Generate Redline as per instructions.
- Generate SOP in accordance to the regulation.
- Generate DCR/DCO after training.
- Maintain and generate CAPA's file (not implement task and actions)
- With oversight from the Core Team Leads (CTL), generate reports, graphical analyses, and trend charting.
- Perform database analyses as directed by CTL (Pareto, trend charting, histogram, etc.)
- Be able to work with various databases to extract and report out required information (Excel, Access, Q-DAS SAP etc.)
- Demonstrated ability to produce accurate, timely and succinct reports and summaries.
- Be able to manage effectively multiple priorities and tasks.
- Work independently and in a team environment.
- Generate SOP as per regulation requested.
- Fluently German mother language/English spoken and written
- 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, customer oriented
- Team player
- Travel required form site to site (10 - 15%)
Experience:
- Minimum of 4 years experience as document writer or similar position.
- Proficiency with a variety of computer software applications in word processing,
Spreadsheets, database and presentation (MS Word, Excel, PowerPoint, etc.).
- Compliance experience in the medical device.
- Familiarity and interaction experience with regulatory auditing bodies preferred.
- Documented training in FDA QSR, ISO 13485/9001 required.
Start: ASAP or latest mid May
Duration: 6 - 9 months
Languages: German and EnglishMichael Bailey International is acting as an Employment Business in relation to this vacancy.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
SAP Entwicklung, Sonstiges