Quality Engineer, MedTech

Responsibilities

• Work on diverse and evolving assignments for various companies to ensure medical device and pharmaceutical safety
• Balance quality and regulatory compliance during product development processes
• Maintain quality standards in highly regulated production environments such as GMP
• Support the introduction of new technology and efficient medical equipment to the market
• Utilize expertise in Design Control, technical documentation, Quality Assurance, or regulatory requirements across projects ranging from startups to international corporations

Requirements

• Engineering degree in biotechnology, medical technology, chemical engineering, or similar
• Experience in product development quality within the MedTech industry (e.g., Design Control, CE marking, QA, Regulatory Affairs, or QMS)
• Experience working in regulated production environments, such as pharmaceuticals
• Strong knowledge of regulatory requirements and standards including MDD/MDR, ISO 13485, ISO 14971, IEC 62304, and GMP
• Fluency in Swedish and English
• Interest in digitalization and software quality assurance for connected equipment is a plus

About the Company

Knightec Group (formed by the merger of Semcon and Knightec) is Northern Europe's leading strategic partner in product and digital service development, helping clients realize strategies from idea to finished solution.