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Analyst Quality Systems - Document Control - Medical Device - Laboratory Automation

We recruit for a confidential Medical Device client. Our client is a Global Player and has more than 80 years experience in the field of Lab Automation. Client's 60,000 associates serve customers in more than 125 countries and generated $16.5 billion of revenue in 2016. Client's systems, found in hospitals and other critical care settings around the world, produce information used by physicians to diagnose disease, make treatment decisions and monitor patients. Scientists use the life science research instruments to study complex biological problems including causes of disease and potential new therapies or drugs.

This challenging position is located in Munich:
 

Analyst Quality Systems - Document Control - Medical Device - Laboratory Automation

 
Description
- Manage the process of Document Control;
- Support development & writing of process documents/procedures based on needs of internal customers;
- Support Training & Development Process;
- Maintain related databases adhering to external and internal requirements;
- Independently synthesize and describe complex scientific data, and be well versed in scientific terminology, principles, and publishing standards;
- Overseeing company Key Performance Indicators and escalating improvement proposals;
- Work efficiently and accurately in content management systems, adhering to best practices and departmental standards for terminology, content management, and reuse;
- Ability to quickly establish credibility and trustworthiness with key stakeholders;
- Able to successfully manage multiple projects from concept to release under tight deadlines while coordinating input from numerous sources;
- Communicates project status and issues to Project Teams, Project Management Analysts, Technical Writers, Coordinators, and Management;
- Participates in process improvement effort

Qualifications
- A Bachelor’s degree or Master’s degree with 5+ years of experience, preferably in areas of life sciences, engineering, or quality assurance, Bachelor of Science in Technical Writing and Communication or equivalent
- At least 3 years of experience in Technical Writing of Functional Specifications and Design Documents for highly complex multi-disciplinary systems.
- Professional designations are not required but training and certificates in quality or regulatory affairs would be a plus (e.g. CQM, CQE, CQA, RAC, CLIA, Six Sigma, Lean Principles).
- Excellent command of verbal and written English, writing, grammatical, and editorial skills
- Excellent command of document styles, standards, and guidelines
- Excellent command of documentation taxonomy and hierarchy
- Working knowledge of Microsoft Office and Storyline applications
- An understanding of FDA and other compliance regulations such as 21 CFR 11, IEC 62304, IEC 62366, ISO 9001, ISO 13485, and ISO 14971 is preferred
- Experience with the medical device industry within a Quality Assurance or Information Technology group is preferred
- Must be able to demonstrate skills in root cause investigation and problem solving
- Experience in the use of 5 Whys or other appropriate root cause investigation tool(s)
- Must have critical thinking skills and good judgment working in an independent environment
- Goal oriented, interpersonal, self-motivated and team player

The job is limited for 2 years. But the Quality Department has a lot of options to offer for your individual development and further unlimited employment.

If you are interested and qualified, please send us your resume as a Doc, RTF or PDF-File in English.
 
Kategorie Technical Writing Ansprechpartner BANDAO Unternehmensberatung GmbH
Mr. Markus Moser
Schloßbergstraße 1
D-82319 Starnberg
Tel. :+49-8151-555 1 666
E-Mail: job@bandao.de
www.BANDAO.de
Markus Moser
Branche Medical Device
Einsatzort München
Beginn sofort
 
 
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