Quality Assurance Manager Operations
Posted on May 26, 2021 by ITech Consult
Quality Assurance Manager Operations - quality management, stakeholder management, MES
For our client Roche, based in Rotkreuz we are looking for aQuality Assurance Manager Operations.
The Department Quality Operations is looking for a highly motivated and committed Operations Quality Assurance (OpsQA) Manager with experience in the product care of medical devices/IVDs. The Operations Quality Assurance department consists of 35 persons and you will be working in a team of 10. Our team covers sensors, reagents and instruments for blood gas analysis. As a Quality Assurance Manager Operations you work with BG/E (Bloodgas & Electrolytes) Operations 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.
Areas of responsibility:
* Support and enable our business partners regarding product care and product improvement activities as well as in all other quality aspects within the area of responsibility.
* Ensure product quality and compliance to the regulatory requirements and the proper documentation of all activities
* Quality responsibility for - Documents: Support business partners, review and approve documents, templates and records to ensure product quality and compliance - Change management: Support business partners, review and approve changes to ensure product quality and compliance - Deviation management: Support business partners, review and approve deviations to ensure product quality and compliance - Process Risks: Support business partners, review and approve pFMEA to ensure product quality and compliance
* Support special projects or initiatives in the area of Quality and business partners
* Permanently optimize processes in order to increase quality and efficiency standards
Professional and technical requirements:
* Technical or scientific degree or completed education in a technical profession.
* At Least 3 years professional experience with the medical device regulations including ISO 13485 and FDA regulations for the above mentioned processes
* At least 3 years professional experience with working in process improvement projects
* Solid experience with quality management
* Solid experience in a demanding interface role in a complex environment, good stakeholder management skills across all hierarchy levels to ensure a successful communication
* Very good German language skills (B2 or higher) and good English verbal and written language skills
* Experience of bringing MES to production is a plus
* Flexible and team player personality with the ability to assert yourself. You are used to working independently and are a strong communicator.
* solution-oriented mindset
* self-dependent, structured, quality oriented and determined
Reference no: 920328 AD
Role: Quality Assurance Manager Operations
Industry: Pharmaceutical industry
Location: Rotkreuz, Switzerland
Start date: ASAP
Duration: 12 months contract, with possible extension
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.