QA/RA Specialist

Raysearch Laboratories • Stockholm, ME

63d • Onsite

About The Position

As one of our QA/RA Specialists, you will join a team of ten dedicated coworkers. The role requires previous experience from maintenance of Quality Management Systems (QMS), including document management, CAPA management and change management. Proven experience from planning and leading a QMS migration project successfully is a must. The QA/RA team is central to the company's business as it is responsible not only for the QMS but also for product market clearances, vigilance and internal and external audits. Since the pandemic, the team has grown from seven to twelve members and is expected to continue to grow.

As QA/RA Specialist, you will report to the Quality & Regulatory Affairs Director and be involved in all areas of the department.

The role is a great opportunity for you to contribute to the care of cancer patients by enabling new software innovations to be quickly and reliably supplied to markets worldwide. You will have contact with all departments at our headquarters and work closely with an international team happy to share knowledge.

Requirements

• Knowledge of ISO 13485, MDR or QSR
• Project management experience
• Flexible
• Meticulous
• Structured
• University degree or equivalent
• English at a high business level
• Fluency in business English and experience from medical device software industry is a requirement.

Responsibilities

• Manage the project for transitioning our QMS from one digital platform to another.
• Manage the CAPA process and coach the organization regarding management of individual CAPAs.
• Assist our IT department in validating tools supporting the QMS and in general IT-maturity.
• Manage internal audits, external audits and inspections.

Benefits

• Our modern and creative workspace includes an in-house gym, yoga, and social activities like ping pong, table football, and regular after-work events.
• Our bistro serves a fantastic lunch buffet, and we offer morning- and afternoon-fika every day.
• Our rooftop terrace also provides a stunning 360-degree view of Stockholm, enhancing the work experience.
• All of this comes attached with a competitive compensation and benefits package.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Publishing Industries
• Number of Employees: 251-500 employees