· 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
Internal Number: #898
About Greiner Bio-One N.A.
Located in Monroe, North Carolina, we provide product manufacturing, distribution logistics and production application support to our customers in Life Science and Clinical laboratories through our BioScience and PreAnyalitic business units.
The BioScience business operation of Greiner Bio-One offers products for the cultivation and analysis of cell and tissue cultures, micro-plates for high-throughput screening, allowing industry and research the most rapid and efficient drug screening, a complete line of dependable ready-to-use general lab-ware tools used in laboratories everywhere, and innovative bio-chip technologies for genotyping to detect gene defects and identify infectious agents.
The PreAnalytic business unit at Greiner Bio-One offers solutions for the collection of human samples under the VACUETTE brand name. Our products are designed in close cooperation with customers, and manufactured to meet the regulations of FDA QSR and cGMP, Health Canada and ISO 13485. Our products and the service we provide are geared toward the daily routine of laboratory medicine.
Greiner Bio-One, developed and sold the first plastic evacuation blood collection tube on the market to p...rovide Phlebotomy, Nursing, and Laboratory professionals with a new level of safety and product effectiveness that would help to eliminate the use of dangerous glass tubes. This level of service to the safety of the medical professional continues today in the products we bring to customers. Our products have extensive clinical backing along with educational programs and materials to help assure our customers that they will deliver the best possible results for their patients.