Senior QA Specialist (Medtech)

TL;DR

Senior QA Specialist (Medtech): Ensuring medical device safety and quality compliance within a regulated environment with an accent on internal audits, CAPA processes, and regulatory standards monitoring. Focus on identifying system improvements, managing nonconformances, and maintaining compliance with ISO13485 and MDSAP.

Location: Solna, Sweden

Company

hirify.global provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows.

What you will do

• Support business improvement projects and digitalization efforts.
• Provide quality system support to stakeholders across Manufacturing, Design, Purchasing, HR, and IT.
• Perform internal audits, identify improvements, and track nonconformances to closure.
• Participate in external audit preparation, management reviews, and the CAPA process.
• Monitor and perform gap assessments of new standards and regulations.
• Improve management system procedures and resolve quality issues.

Requirements

• Academic degree (M.Sc or B.Sc) in science or engineering.
• 5-10 years of working experience in a similar quality or compliance position.
• Documented knowledge of regulations and standards such as ISO13485, QMSR, MDSAP, and ISO14001.
• Strong verbal and written communication skills in Swedish and English.
• Experience in a regulated industry, specifically medical device development and manufacturing.
• Strong analytical and administrative skills.

Nice to have

• Experience with product development.
• Experience with software tool implementation.

Culture & Benefits

• Safe and informal work environment with close team collaboration.
• Open dialogue between leaders and employees.
• Personalized plans for learning and competence development.
• Competitive compensation package including wellness allowances.
• Generous family benefits and joint company activities.