Description
Quality Assurance Expert (QA Expert)For our client, a Market Leader in the Medical Device industry, i am looking for an experienced professional supporting the maintenance and improvement of the Quality Management System according ISO 13485 and 21 CFR Part 820 along with the coordination of CAPAs related actions and change management tasks as well as to manage the risk management process, complaint and vigilance activities.
This position requires strategic and tactical talent to manage the activities and to work effectively with departments within the organizations.
Responsibilities:
- Development, maintenance & improvement of the Quality Management System according to ISO 13485 and 21 CFR Part 820
- Management of all Risk Management Activities
- Management of all Complaint handling and Vigilance related tasks (including reporting)
- Responsible for the daily review and analysis of customer complaints and responsible to ensure that complaint investigations are adequate prior to closure
- Escalate any complaints that are potentially reportable and responsible to ensure that risk assessments are conducted as required
- Coordinate CAPA Board Meetings and responsible to ensure documentation is adequate prior closure
- Responsible to drive and monitor continuous improvement of external product quality by applying the company's Customer Defect Tracking and Resolution Process (CDT&R)
- Management of all Post-Market Surveillance (PMS) activities
Qualifications:
- Minimum 3 years proven QA experience with medical devices in an FDA-regulated industry; or equivalent combination of education and experience
- Experience with ISO 13485 and FDA 21 CFR Part 820, US and European regulations
- Experience with Class III medical devices in the U.S. & E.U.
- International experience in CAPA, problem solving, complaint handling or equivalent
- Expertise of writing technical documentation including URS, DHF and instructions for use
- Bachelor's degree (BA/BS) from four-year college or university in science, engineering or equivalent
- English (mandatory), German (preferably)
Key facts:
Start Date: January/February 2018
Length: minimum 6 months
Extension: possible
possible Workload: 100%
If you are interested in discussing further details about this or similar positions, kindly contact me as soon as possible.
Best Regards
Elena Reeb
Recruitment Consultant Medical Devices
Real Ein Geschäftszweig der SThree GmbH Claridenstrasse 34, Zurich, 8002, Switzerland
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Sthree Switzerland is acting as an Employment Business in relation to this vacancy.