· Manage that QM documentation is maintained in accordance with corporate and local regulations and in compliance with valid standards and laws.
· Manage and maintain local electronic Quality Management System (eQMS)
and provide support for local users and HQ.
· Coordination of department access and authorization in eQMS.
· Ensure that corporate and local QM documents are distributed to the points of use within the company.
· Manage the verification and implementation process of source documents
from GBO Frickenhausen and GBO Kremsmuenster in cooperation with the departments in charge.
· Interface for Quality Document Management from GBO corporate and from subsidiaries.
· Perform or support training in departments for compliance with QM
documents and with QS regulations.
· Perform periodic internal auditor training.
· Perform and organize internal, external and Supplier audits together with QRM.
· Maintain training presentations for Regulatory part.
· Manage local Corrective and Preventive Action (CAPA) process in cooperation with Quality System and Regulatory Affairs Manager and Corporate Quality Management.
· Organize and maintain documentation for GBO NA Recalls and Device Reporting (MDR, MPR,..).
· Complete customer questionnaires about our QM system.
· Upkeep of department training documentation.
· Responsible for QMS records storage according to internal and external requirements.
· Assist in regulatory affairs tasks and inquires with current quality
· Assist and/or perform internal or external Audits.
· Other duties as assigned
· QM user access for eQMS
· Write and delete access for QM documents
· Reject QM documents and records when formal or regulatory requirements
· Organize and conduct internal CAPA meetings
· Organize storage of electronic and paper records according to requirements
· Must have at least high school education, preferably college or bachelor degree.
· Audit experience an advantage.
· Experience with Quality System like ISO 9001, ISO 13485 and/or FDA an advantage.
· Good and open communicator. Likes to work with people.
· Great Motivator. Helps and tries to find solutions for problems. Goes extra
mile to help others complete tasks.
· Good organizational skills.
· Accurate, thorough and detailed oriented.
· Must be able to work independently.
· Knows when to compromise and when not to compromise based on quality
or regulatory requirements.
· Is able to lead local organization in regards to fulfill QM documentation requirements for passing internal and external audits.
· Knowledge of basic regulatory and QM System standards preferred.
· Must have very good communication and writing skills in English.
· Must pass pre-employment examination, qualification test
· Must be able to sit, stand, walk for longer periods of time