Quality Assurance Manager 100%

SCHILLER AG is an international, renowned medical engineering company, leader in cardiopulmonary diagnostic devices, patient monitoring, defibrillation, emergency care, as well as software solutions in the medical sector. Our products are developed and manufactured in Switzerland and distributed to clinics and medical practices around the world.

We are looking for an objective Quality Assurance Manager to add value and improve our operations by bringing a systematic and disciplined approach to the effectiveness of risk management, control and governance processes. The successful candidate will possess a thorough knowledge of ISO 13485 and FDA QSR requirement plus a sound judgement.

Your Responsibilities

• Principle risk process owner including process document update according to regulatory requirements


• Principle quality reviewer of Design History File for the assigned device groups


• Responsible for risk assessment of potential reportable complaints


• Be the direct contact person with competent authorities and within group companies for vigilance reporting and field safety and corrective action coordination internationally


• Involved in quality process audit with reference to GHTF nonconformity grading system including risk management and compliance with all applicable directives and regulations


• Supporting on necessary quality training including new employee’s quality training and process maintenance training


• Act as an objective source of independent advice to ensure validity, legality and goal achievement


• Actively involved in quality projects


• Support necessary supplier audit when required

Our Requirements

• Proven working experiences for risk management


• Bio-medical Engineering degree or equivalent and have practical quality experience minimum two (2) years in a medical device company


• Fluent in English and German


• High attention to detail and excellent analytical skills and to make conclusion


• Proven knowledge of auditing standards and procedures, laws, rules and regulations and ISO 14971


• Ability to work for multi-task simultaneously and under time pressure


• Excellent planning skills and well-organized working style


• Advanced computer skills on MS-Office and databases


• Sound independent judgement, open-minded

Are you interested in joining Quality Assurance and would like to take a next step for job rotation? We offer an exciting tailored career path for your professional and personal development within our Team.

Have we caught your interest? Then please apply online or send your application to:

SCHILLER AG, Ms. Andrée Steffen, Human Resources, Altgasse 68, 6341 Baar

For further telephone enquiries please contact Ms. Dr. Zhenrong Yu, 041 766 42 42.

Please note that only direct applications can be considered.