Beschreibung
currently we have a very interesting project opportunity for a global plaver in the medical device industry in cologne. We are looking for you as a Senior Manufacturing QA Engineer!Assists in transfer of new products to manufacturing by assisting in the development of equipment and process validation requirements (FMEA, IQ, OQ, PQ) using appropriate statistical tools and techniques.
Provides engineering support to manufacturing and resolve issues impacting production fulfillment specifically nonconforming material.
Generates internal quality documentation such as quality plans, SOPs and inspection procedures. Ensure QA, FDA and ISO compliance in all areas of responsibilities.
Participates in Quality Review Boards. Identify non-conformance trends and develop technical investigation plans. Investigates and analyze customer/internal complaints.
Spends time on the manufacturing floor to determine process improvements and interface with all cross functional departments to improve product quality.
Provides all planning necessary to ensure effective product acceptance based on DMR.
Assists in the improvement of process flow and part manufacturability with LEAN methodology.
Assists in implementation of QA plans, process controls, and CAPA systems designed to meet internal and external requirements.
Assists in defining requirements for Automated Processes.
Provides manufacturing engineering information by answering day-to-day compliance questions and requests.
Participates in internal and external quality audits.
Leads and/or participate in process validation and risk management activities.
Certified ISO 13485 Lead Auditor preferred
Knowledge of the FDA GMP, ISO 13485.
Knowledge of six sigma methodologies; Black Belt certification preferred.
Experience in managing/coordinating engineering activities
Good verbal & written communication skills.
If you are interested, please provides us with your CV as soon as possible. Reference :J Duration :12-18 Monate Location : Köln Languages : Englisch emagine GmbH Djuheric, Mirza T : F :