Ensures establishment and maintanance of Quality System according to applicable government regulations and standards e.
g. ISO 13485, 21 CFR 820 QSR, MDD 93 / 42 / EEC
Supports project managers on optimal use of RA / QA resources within the projects e.g. regarding product risk management according to ISO 14971
Provides RA / QA support of Engineering teams responsible for developing medical device software in compliance with IEC 62304 Medical device software -
Software life-cycle processes
Supports Regulatory Affairs regarding regulatory submissions e.g. 510(k) submissions containing medical device software
Is a member of the management team and the Management Representative according to ISO 13485
Is accountable for reporting on the performance of the overall Quality System
Coordinates the forum for conducting management review and collects data for management review
Manages FDA inspections, the CAPA program, and the overall audit program including internal, supplier, and external audit (e.g. TUV)
Coordinates and performs quality training
Defines goals and objectives and measures employee performance against defined objectives and within budget
Bachelor's Degree in Computer Science, Engineering or related technical field required. Masters Degree or equivalent preferred
Ideally 10 years industry experience working for multinational medical device manufacturer(s) (or similar regulated industry)
8-10 years management experience or supervisory equivalent providing leadership to the team as well as internal and external stake holders
Ability, competence, and confidence to lead people
Effective interpersonal and communication skills
Sound knowledge and working experience of Quality management system, standards and government regulations applicable to medical devices e.
g. ISO 13485, 21 CFR 820 QSR, MDD 93 / 42 / EEC, EU MDR
Professional certification is desirable (i.e. SQA-Software Quality Assurance, CQM-Certified Quality Manager)
For further information about this vacancy please contact our recruiter : Deniz.Guergen varian.com
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