Senior Quality Systems Specialist / Internal Auditor

My client is an international company from NRW near Köln. It´s a very innovated medical device company who is looking for a Senior Quality System Specialist and internal Auditor to improve their production department.

Job Qualification

•BA/MS plus several years experience in related or equivalent industry
•FDA Quality System Requirements: ISO 13485, ISO 9001
•ANSI/AAMI SW 68, and ISO 14971 risk management standards
•Six Sigma, M3K, etc.
•Background in one or more of the following areas desired
•Familiarity with radiation therapy helpful
•excellent verbal and written communication skills
•Interacting with all levels of managements, co-workers, and regulators
•english fluent for international travels


Job Description

•FDA Quality Systems Regulation (QSR), ISO 13485, ISO 9001
•Writing SOPs, work instructions, quality and control plans etc.
•CAPA process
•internal audits and Compliance with audit programs
•reporting results to management
•Plan and perform support activities/ lead and coordinate site activities
•validation protocols and test reports
•FMEA/FTA
•Work closely with different departments
•Assist with FDA inspections

For further information about this great opportunity, please e-mail or call Agnes Wydra (Quality Management Recruitment Consultant) at Real Pharma on 0049 (0) 69 26 489 8400.

a.wydra(at) realstaffing.com

(Real Staffing Group acts as an Employment Agency and an Employment Business)