Senior Supplier Development Quality Engineer (Medtech)

Location: Stockholm, Sweden; office work four days per week, with approximately 10% travel.

Company

hirify.global develops precision radiation medicine and radiotherapy solutions used by healthcare providers in more than 130 countries.

What you will do

• Manage supplier quality issues, containment, root cause analysis, and corrective actions.
• Monitor supplier performance and conduct supplier approval, surveillance, capability, and quality management system audits.
• Lead supplier development and continuous improvement initiatives using structured quality and operational excellence methods.
• Plan and document Supplier First Article Inspections and Production Part Approval Processes for new or changed parts.
• Maintain supplier documentation, approvals, and Quality Assurance Agreements in an audit-ready state.
• Perform quality control activities for installed Leksell Gamma Knife systems and collaborate with Procurement, R&D, Manufacturing, Service, and suppliers.

Requirements

• Bachelor’s or master’s degree in engineering, or equivalent relevant experience.
• At least five years of engineering, manufacturing, supplier quality, or supplier development experience in a regulated industry.
• Experience conducting supplier or quality management system audits; Lead Auditor certification is advantageous.
• Knowledge of ISO 13485, ISO 9001, ISO 14001, ISO 14971, or 21 CFR Part 820.
• Experience with 8D, 5 Whys, Lean, Six Sigma, risk management, and continuous improvement methods.
• Professional written and spoken English is required; Swedish is an advantage. Willingness to travel approximately 10% of the time is required.

Culture & Benefits

• Collaborative office environment with cross-functional cooperation.
• 30 paid vacation days per year and four additional hirify.global days off.
• Defined contribution pension scheme and private medical insurance.
• Lunch benefit and contribution to wellness activities.

Hiring process

• Submit a CV in English through the application portal.
• Applications are reviewed on an ongoing basis.