QA Specialist

Quality & Regulatory
SE Gothenburg
Join Our Team as a QA Specialist at Ascom!

About Us: At Ascom, we are dedicated to delivering innovative communication solutions that empower healthcare providers and enterprises worldwide. As a global leader in our industry, we pride ourselves on maintaining the highest standards of quality and regulatory compliance.

The Role: We are on the lookout for a proactive and experienced QA Specialist to join our dynamic team. In this pivotal role, you will be the Management Representative for our assigned region, ensuring adherence to the Ascom Integrated Management System (IMS) across all products and processes. You’ll play a critical role in maintaining and enhancing our quality standards, serving as a Subject Matter Expert for dedicated standards and processes.

What You’ll Do:

• Manage and Document: Oversee essential processes for our quality management system.
• Report and Recommend: Evaluate the effectiveness of our Management System and suggest improvements to top management.
• Develop and Enhance: Align our Management System with global standards and regulatory requirements.
• Lead and Improve: Drive initiatives to boost process effectiveness and efficiency within the region.
• Audit and Coordinate: Conduct and oversee QA/RA audits, both internal and external, and manage Corrective and Preventive Actions (CAPA).
• Train and Guide: Provide training and guidance on QA/RA tools and methods across the organization.

What We’re Looking For:

• Technical Expertise: Advanced knowledge of quality tools and methods (e.g., validation, CAPA).
• Regulatory Know-How: Understanding of regulatory requirements (e.g., MDR/ISO 13485).
• Project Leadership: Ability to lead projects in a regulated environment.
• Risk Management: Familiarity with ISO 14971 and usability risks.
• Customer Focus: Prioritize customer needs and satisfaction.
• Strong Communication: Excellent communication skills, both internally and externally.
• Leadership Skills: Capability to lead initiatives and collaborate effectively.
• Industry Insight: Understanding of healthcare and enterprise industry dynamics.

Your Background:

• Education: Bachelor’s degree in Engineering, Biomedical Technology, or a related field.
• Experience: 3-5 years in product development, manufacturing, or quality control within the medical device industry or similar regulated sectors. 1-2 years in conducting audits and managing QA/RA processes.

Why Join Us?

• Competitive Salary: A package commensurate with your experience.
• Career Growth: Opportunities for development within a global organization.
• Comprehensive Benefits: Including health insurance and retirement plans.

Ready to Make a Difference? If you are passionate about quality assurance, regulatory compliance, and making a difference in a dynamic and innovative environment, we invite you to apply for the QA Specialist position at Ascom. Take the next step in your career and contribute to our mission of delivering excellence in communication solutions globally.

Apply Now and Join Our Team!

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