QA Project Manager Combination Product and Device (m/f)

REFERENZNUMMER:

311449/11

IHRE AUFGABEN:

-Collaborate with all QA representatives and serve as the single point of contact with regard to Quality for allocated device development project
-Ensure all projects follow the applicable risk management procedures, design control activities, design history file and prepare control strategy definition
-Create and deploy risk management plan, actively participate up to facilitating FMEAs, define delivery system specifications and ensure all necessary release GMP documentation are completed and in place from incoming to release of combination product
-Represent department at quality review board and change review board meetings

IHRE QUALIFIKATIONEN:

-Degree in life sciences or chemical/mechanical engineering
-Expertise in device manufacturing and experience in risk management concepts and tools, and deploying design control
-Understanding of the biotechnology industry and specifically of combination products
-Sound knowledge of cGMPs, quality systems regulations and medical device directives, ISO 13485, ISO 14971
-Fluency in German and English

WEITERE QUALIFIKATIONEN:

Project manager, Quality manager