Instrument Design QA Lead — Medical Device Quality

Neko Health; Stockholms kommun; On-site; SEK 597,760 - 815,128; Full time

Job summary

A cutting-edge health technology company in Sweden is seeking an Instrument Design QA Lead to ensure quality and compliance of their medical devices. You will manage all aspects of quality assurance, driving design control and risk management across the product lifecycle. The ideal candidate has significant experience in the medical device sector, deep knowledge of regulatory standards, and strong project management skills. This role requires excellent collaboration with engineering teams to ensure every product meets safety and effectiveness criteria.

Qualifications

• 5+ years of experience in the medical device industry focusing on hardware or firmware.
• Strong knowledge of EU MDR, ISO 13485, and FDA regulations.
• Experience participating in audits and regulatory submissions.

Responsibilities

• Lead QA for a product family ensuring compliance with ISO and FDA standards.
• Drive risk management and design controls throughout the product lifecycle.
• Coordinate technical documentation for regulatory submissions.

Skills

Design controls expertise

Risk management

Technical documentation

Project management

Fluent English

Education

BSc or MSc in engineering, biomedical engineering, systems engineering, or physics

Tools

eQMS

Modern digital tooling

Job description

A cutting-edge health technology company in Sweden is seeking an Instrument Design QA Lead to ensure quality and compliance of their medical devices. You will manage all aspects of quality assurance, driving design control and risk management across the product lifecycle. The ideal candidate has significant experience in the medical device sector, deep knowledge of regulatory standards, and strong project management skills. This role requires excellent collaboration with engineering teams to ensure every product meets safety and effectiveness criteria.