Senior Quality Assurance Specialist and Supplier Auditor (Medical Devices)

Location: Based in Solna, Stockholm, Sweden; a hybrid working arrangement may be possible depending on business needs. The role involves approximately eight supplier audits annually and additional supplier- and audit-related travel.

Company

Global medical technology organization providing products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing, and life science institutions.

What you will do

• Participate in the global Supplier Auditor team and collaborate with Procurement, Supplier Quality Engineers, and suppliers.
• Advise stakeholders on supplier qualifications, quality agreements, and quality-related matters.
• Maintain and improve the Quality Management System and related procedures.
• Conduct internal audits, identify improvement opportunities, and track nonconformities through closure.
• Prepare for external audits and management reviews while supporting CAPA activities.
• Conduct approximately eight supplier audits annually and support related supplier quality activities.

Requirements

• Academic degree at B.Sc. or M.Sc. level in Engineering, Science, or a related field.
• At least five years of experience in a similar quality-related role within a regulated industry, preferably medical devices.
• Experience with supplier controls, supplier audits, and quality management systems.
• Documented knowledge of ISO 13485, MDSAP, QMSR, ISO 9001, and ISO 14001.
• Strong spoken and written Swedish and English are required.
• Experience working cross-functionally in a global organization, with strong analytical, communication, and stakeholder-management skills.

Nice to have

• Experience with sustainability-related requirements and initiatives.
• Experience in the medical device industry.

Culture & Benefits

• Collaborative, proactive, and continuous-improvement-oriented quality and compliance environment.
• Opportunity to contribute to the safety and quality of life-saving medical devices.
• Competitive compensation and benefits package.
• Wellness allowance and generous family benefits.
• Joint company activities and support for employee well-being and professional goals.

Hiring process

• Applications are reviewed continuously, so early submission is recommended.
• Applications must be submitted through the recruitment system; applications by email are not accepted.