Beschreibung
Quality Assurance Manager for Consumables (f/m/d) - Quality Management / ISO13485 / Q&V / FDA / EnglishProject:
For our customer Roche Diagnostics International AG based in Rotkreuz we are looking for a highly qualified Quality Assurance Manager for Consumables.
Background:
The Operations Quality Assurance department consists of 60 people and you will be working in a team of seven, which covers the quality support of our consumables products. As an Operations Quality Assurance Manager, you work with our Consumables Operations department to ensure that Roche 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 perfect candidate:
We are looking for a highly motivated and committed Operations Quality Assurance (OpsQA) Manager with experience in the product care of medical devices / IVDs, who is willing to work in a fast changing and growing environment. You are open for new ideas and challenge conventional thought patterns. You are excited to work in a performance-oriented environment where mutual respect, discussions and cooperation are key. Roche is your starting point in an exciting international work environment with varied development opportunities.
Tasks & Responsibilities:
- Support and enable the business partners 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 our business partners by reviewing and approving project-, product- and process documents, changes and deviations, Q&V activities and 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
Must Haves:
- Academic degree in an engineering or life science discipline or related work experience in Quality Management
- Min. 3+ years' experience with the medical device regulations including ISO 13485 and FDA regulations for the above-mentioned processes
- Min. 3+ years' experience in Quality management, Quality Assurance or Quality Control, preferred in the medical device industry at least in the regulated industry
- Technical and/or scientific understanding to be able to work with Business and Technical stakeholders
- Hands-on experience in leading a process improvement project
- Fluency German and English, spoken and written (min. B2 Level in both languages)
- Strong communication skills
- Good stakeholder management skills across all hierarchy levels
- Self-dependent, structured, quality oriented and determined
- Solution-oriented mindset, active and initiative personality
- Crucial contribution to the spirit of the existing team
Nice to have:
- SAP Skills
- Knowledge of Injection Molding
Reference Nr.: 921856
Role: Quality Assurance Manager for Consumables
Industrie: Pharma
Workplace:Rotkreuz
Pensum: 100%
Start: 01.10.22
Duration: 12++
Deadline: 25.08.22
If you are interested in this position, please send us your complete dossier via the link in this advertisement. If this position does not fit your profile and you wish to be considered for another position directly, you can also send us your dossier via this ad or to jobs[at]itcag[dot]com.
Contact us for more information about our company, our positions or our attractive Payroll-Only programme: .
About us:
ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specialises in the placement of highly qualified candidates for recruitment in the fields of IT, Life Science & Engineering.
We offer staff leasing & payroll services. For our candidates this is free of charge, also for Payroll we do not charge you any additional fees.