Product Support Quality Assurance Specialist
vor 2 Monaten
Distalmotion SA is a leading medical device company that aims to deliver the benefits of robotic surgery to more surgeons, more hospitals, and more patients globally. Our vision is to establish a new standard of care, removing traditional barriers and complexities of robotics to ensure greater access to best-in-class minimally invasive surgery.
We are a diverse, international team, headquartered in Switzerland, with a growing presence and footprint globally. With over 150 members, more than 25 nationalities, speaking over 15 languages, we are all united by the same goal — bringing patients the best in minimally invasive surgical care.
About the RoleThe Product Support Quality Assurance Specialist will be responsible for investigating product and customer complaints, carrying the 'voice of the customer' into product development and CAPA boards to drive continuous product and service improvement. This role has a direct impact on Distalmotion SA's products quality improvement and customer satisfaction.
Key Responsibilities- Complaint Handling:
- Develop and continuously improve complaint handling tools and processes to ensure reportability compliance, customer satisfaction, and drive product continuous improvement.
- Review complaint databases daily for reportability evaluation.
- Liaise with Clinical Specialists and/or Field Service for complaint records completeness.
- Ensure timely investigation and closure of complaints.
- Involve in related CAPA, R&D, PMO, Training reviews to report on product complaints.
- Lead monthly Customer Complaint Boards providing complaint overviews to management.
- Report on product complaint data for Post Market Surveillance reviews.
- Product Support:
- Manage returns of failed products from the field.
- Lead cross-functional teams for timely and effective investigations of returned products, including performing investigations of contaminated products in laboratory environments.
- Create and maintain work instructions for service, repair, and testing processes.
- Support Field Service and Product Support teams for implementation of CAPA and Field Actions to address customer complaints.
- Other Responsibilities:
- Support Finished Product Release, monitor compliance with procedures, perform internal audits, and update QMS documentation accordingly.
- 3 to 5 years of similar QA experience in a medical device company developing, manufacturing, and marketing technically complex equipment, including hardware, software, and mechanics.
- Degree in Engineering.
- Significant knowledge of medical devices Quality Management Systems (ISO-13485, 21CFR part 820 quality) and regulatory landscapes (MDD, MDR).
- Experience in complaint handling is a must.
- Risk management as per ISO 14971.
- Good communication skills to share Quality and Customer Focus visions within the company.
- English and French fluency.
- Opportunity to work in a fast-growing company active in one of the most promising fields of medicine.
- A dynamic atmosphere in an internationally-minded environment.
- Permanent contract with 25 days of paid vacation.
- Benefit from one day to two days per week working remotely to boost flexibility.
- Attractive talent development programs and initiatives empowering employees to enhance their skills and fostering professional development growth.
- Mobility plan, competitive company pension plan, support for gym memberships.
- Regular team-building events such as boot camps, skiing, and more.
Distalmotion SA is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We provide equal employment opportunities to all qualified applicants and employees.
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