Process Engineer / QMS Analyst – Medical Device Software

About the role

You will join an innovative US‑based medical device manufacturer and take part in the full development life‑cycle of software that processes data from medical devices to identify health trends and track daily activities.

Key responsibilities

• Lead the review and approval of project documentation such as development plans, verification test plans and reports.
• Review and approve Computer Software Validation (CSV) documentation.
• Assess project activities and deliverables against QMS procedures, ISO standards and FDA regulations.
• Advise R&D teams on process implementation and adjustments.
• Collaborate with engineering, product and support teams to ensure quality and regulatory compliance.
• Communicate with customers on quality assurance, process management and documentation topics.

Required profile

• 2‑5 years of experience in IT, software quality assurance, process engineering or related fields.
• Strong knowledge of international quality management standards (ISO 9001:2015, ISO 13485) and FDA QSR (21 CFR Part 820).
• Experience with risk management techniques (FMEA, FTA) and medical device software standards (IEC 62304, ISO 14971).
• Good understanding of software V&V, testing methodologies and documentation management.
• Excellent analytical skills, attention to detail and ability to work with large amounts of information.
• Upper‑intermediate English proficiency.

Required skills

• ISO 9001:2015
• ISO 13485
• FDA 21 CFR Part 820
• ISO 14971
• IEC 62304
• FMEA
• FTA
• Software V&V
• Software testing
• Risk Management
• CSV documentation