Quality Assurance Manager
Posted on Sep 4, 2020 by ITech Consult
Quality Assurance Manager- validation/English/FDA/ISO13485/German
For our a big pharmaceutical company in Rotkreuz we are looking for a highly motivated and qualified Quality Assurance Manager
The Operations Quality Assurance department consists of 35 people and the contractor will be working in a team of five, which covers the quality support of our consumables products. There are three different groups within the OpsQA department: System, Development and Production. The contractor will join the Production team which is responsible for QA Support, batch release and consulting of business partners.
Tasks & Responsibilities:
The Quality Assurance Manager Operations works with Global Operations to ensure that procedures, applicable regulations and standards (regulatory requirements of United States Food and Drug Administration, In Vitro Diagnostics Directive of the European Union, ISO 13485, etc.) are followed during manufacturing.
The main tasks are:
* Support and enable the business partners during a time of increasing production volumes/regarding product care and product improvement activities as well as in all other quality aspects of the consumables products
. Ensure product quality and compliance to the regulatory requirements and the proper documentation of all activities
. Support of business partners by reviewing and approving documents, changes, deviations/Reviewing and approving Q&V activities/Releasing Products
. Ensure improvements through CAPAs, SCARs and process updates
. Lead and/or support special projects or initiatives in the area of quality and of our business partners
. Permanently optimize processes in order to increase quality and efficiency standards
* completed (further) education in med-tech and quality area
. 5+ years of professional experience with the medical device regulations including ISO 13485 and FDA regulations
. Strong communication skills in both German and English
. Quality management experience
. Able to lead a process improvement project
. Technical and/or scientific experience and understanding
. Good stakeholder management skills across all hierarchy levels
. Knowledge of Injection Molding
. Technical or scientific university degree is a plus. (Specific education in med-tech and quality area is more important)
. SAP experience a plus (can be trained after start as well but since team is working with SAP the onboarding will be faster if candidate has already experience)
* Self-dependent, structured, quality oriented and determined.
. Crucial contribution to the spirit of the existing team
. Having a solution-oriented mindset
Reference No.: 919658SGRRole: Quality Assurance Manager
Industry: Pharma Location: Rotkreuz Workload: 100% Start: 16.09.2020 Duration: 12++
Should you find yourself suitable for this position then please send us your complete CV using the link in this advert.
ITech Consult is a certified ISO 9001:2015 Swiss company with offices also located in Germany and Ireland. ITech Consult is specialised in delivering IT candidates for contract work. We were founded in 1997 by IT professionals; hence we well understand what it means to be professionally supported in your search for a new project and being employed.