Beschreibung
RA / QA Specialist focusing on CAPA ManagementAn internationally renowned manufacturer and distributor of scientific instrumentation. The client prides itself on providing the most innovative solutions to our customers' needs for measurement and analysis. The client offers competitive benefits including medical, dental, vision, prescription, long term care, life insurance, STD, LTD and 401 (k).
Description
- 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
- Responsible for preparation and submission of adverse event reporting and recall submission and reporting
- Coordinate CAPA Board Meetings and responsible to ensure documentation is adequate prior closure
- Responsible that all CAPA`s are closed in time or escalated in time if potentially overdue. Responsible to drive and monitor continuous improvement of external product quality by applying the company's Customer Defect Tracking and Resolution Process (CDT&R).
Qualifications
- Minimum 5 years proven RA and/or QA experience with medical electrical devices in an FDA-regulated industry; or equivalent combination of education and experience
- International experience in problem solving, complaint handling or equivalent
- Bachelor's degree (BA/BS) from four-year college or university in science, engineering or equivalent
- Knowledge of US and EU medical device regulatory requirements
- English (mandatory), German preferably
Should you be interested in this or similar Projects, please do not hesitate to contact me and send me your newest CV.
Best Regards
Sabina Keel