Quality Systems Specialist
1 month ago
RequirementsMinimum 2 years of experience working with Quality Management Systems in the regulated industry (Medical Devices). Experience in Trackwise and MAP Agile tools. Bachelor Degree Completed.
Preferred Qualifications:
Strong understanding of global regulatory requirements for medical devices including FDA regulations (e.g. 21CFR Part 820) ISO 13485 Medical Device Directive and European Medical Device Regulation.
Experience defining driving and implementing process improvement and functional excellence efforts.
Strong organizational skills and time management skills
Ability to multitask support multiple projects function globally prioritize conduct team meetings and meet project deadlines.
Proven experience in achieving results through influence management and motivating teams.
Good communication (oral and written) presentation and interpersonal skills.
Ability to work in a team environment as well as independently
A continuous improvement mindset
Exhibits high degree of initiative and good judgment.
Experience working with Change Control CAPA documentation audit and/or training
Trackwise and MAP Agile tools knowledge High level of communication English language skills
Education
Bachelor Degree Completed.
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