Who We Are
Roche Diagnostics International Ltd in Rotkreuz is one of the world’s leading providers of diagnostic system solutions for clinics, laboratories and doctors’ offices. The company employs over 2200 people in Rotkreuz and is one of Roche Diagnostics main sites.
Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
We are currently looking for a highly motivated and committed Operations Quality Assurance (OpsQA) Manager for our team with experience in the product care of medical devices / IVDs.
The Operations Quality Assurance department consists of 45 persons and you will be working in a team of 10. Our team covers a wide product range of IVD devices, including hardware, software and disposables.
As a Quality Assurance Manager Operations, you work with Operations to ensure that Roche procedures, applicable regulations and standards (regulatory requirements of United States Food and Drug Administration, In Vitro Diagnostics Regulation of the European Union, ISO 13485, etc.) are followed during manufacturing.
The advertised position offers:
You support and enable our operations business partners regarding product care and product improvement activities as well as in all other quality aspects within the area of responsibility.
You ensure product quality and compliance to the regulatory requirements and the proper documentation of all activities.
In your role as quality responsible person, you support our business partners, review and approve changes, deviations and documents to ensure product quality and compliance.
You are the quality responsible person for design transfer or technical product transfer projects to ensure product quality and compliance.
You lead and/or support special projects or initiatives in the area of Quality and business partners
You permanently optimize processes in order to increase quality and efficiency standards
Who you are
You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.
To be successful in this role:
You have recently graduated with a Bachelor’s or Master’s degree in an Engineering or Life science field or equivalent experience with a focus on hardware engineering.
You bring along professional experience in Quality Management with the medical device regulations including ISO 13485 and FDA regulations for the above-mentioned processes.
You have experience in process risk analysis (pFMEA) and verification of product changes.
You have strong communication skills in both German and English.
You are able to lead a process improvement project.
You excel in a demanding interface role in a complex environment and have a solution-oriented mindset as well as good stakeholder management skills across all hierarchy levels.
You describe yourself as self-dependent, structured, quality oriented and determined.
You contribute crucially to the spirit of the existing team.