Arbetsbeskrivning

Are you a dedicated QA/RA professional with a passion for the medical device industry and leadership? We are looking for an experienced QA/RA Manager to take on a central role in guiding and supporting a team of QA/RA consultants, our customers and overseeing diverse assignments and projects, and driving operational excellence.

As Manager QA/RA, you will lead a team of highly skilled QA/RA consultants, working on establishing a harmonious, efficient, and profitable team where employee competence and increasing customer assignments are key to success..

Your role will involve strategically managing resources, customer collaboration, and ensuring the best suitable support for our customers, in compliance with industry regulations such as ISO 13485, MDR, IVDR, and other relevant standards.

Key Responsibilities

In this role, you will:

• Lead and mentor a team of QA/RA consultants, creating an environment where collaboration and performance thrive. Manage resources to align with project goals and deliver exceptional results.
• Work closely with our customers, to oversee their need for support, and provide them with suitable solutions. Increase customer assignments by additional sales
• Support our Sales Director in customer meetings and writing quotes. Support our Marketing director in creating and participating in marketing activities.
• Ensure quality assurance and regulatory compliance projects are effectively planned and executed, maintaining high standards of quality and efficiency.
• Drive continuous improvement by identifying opportunities to enhance processes, streamline operations, and optimize resource utilization. Support the QA/RA Director to be cost effective and fulfilling the budget.
• Take on additional relevant tasks assigned by the QA/RA Director to contribute to the overall success of the organization.

Qualifications and Skills

To excel in this role, you should hold a degree in a relevant field (e.g., engineering, life sciences) and have a minimum of five years of experience from the medical device industry in QA/RA. You should have a broad experience including such as implementing and maintaining a quality system, support in the development process, technical documentation, regulatory approvals and communication with notified bodies/authorities. You should also have excellent communication and interpersonal skills, strong problem-solving and decision-making abilities, and proficiency in both spoken and written Swedish and English.

Why Join Us?

By joining our team at our Stockholm office, you will play a central role in advancing innovative projects in quality assurance and regulatory affairs, while leading a talented group of professionals. This is an exciting opportunity to contribute to meaningful work in a supportive and dynamic environment.

The last day to apply is January 10th. If you are ready to take the next step in your career and embrace this exciting challenge, we encourage you to apply today and become an integral part of our mission.