Beschreibung
Task:- Responsible for supporting the activities of the Quality Control associates
engaged in sorting, testing, and inspecting products and raw materials in order to ensure
compliance with quality standards and production schedules.
- Responsible for managing and coordinating the activities of the execution of Quality Systems
(QS) at site level Internal Audit (lA) Observations, Product Quality Escalation to ensure systems
meet all business and regulatory requirements. Manage the performance and communication of QS metrics at site level.
- Support site readiness in the deployment of these OS initiatives.
- Support compliance and continuous improvement of the Quality System. Support document
control area where needed
- Implements methods and procedures for inspection, testing and evaluation.
- Key contact for inspection and test problems and trains/ coaches the execution of inspections/
tests as well as the handling of measuring devices
- Communicates department objectives and metrics.
- Fosters teamwork and supports total associate involvement
- Reports accidents, incidents, near misses, and hazardous situations in a timely manner and
participates in the corrective action process
- Review site CAPAs, lA Observations
- Support on-site QPR and QSMR, including coordination, preparation, execution, and tracking of activities
- Ensure timely escalation of product quality and compliance issues to the proper source (NC,
CAPA, Product Quality Escalation)
- Supports compliance activities by participating in audit readiness; assisting in Internal and
External audits
Requirements (Must have):
- University/Bachelors Degree or Equivalent in a Life Science, Engineering, or Physical Science.
- Knowledge of regulation and standards like ISO 13485, 21 CFR 820, FDA
- Communication skills
- Able to communicate and writing skills in English
- People Management Skills
- German: very good in spoken, good in written
Environment/Miscellaneous:
- Fulltime in Salzburg
Beginn: 01.09.2016
Dauer: 30.06.2018
Branche: Medizin/Healthcare