Medical Device QA Lead – Regulatory & CSV Focus

Hitachi Vantara Corporation; Kraków; On-site; PLN 169,000 - 254,000; Full time

Job summary

A global medical technology organization based in Poland is seeking a Quality Assurance Specialist to lead quality reviews and ensure compliance with regulatory standards. Candidates should have at least 3 years of experience in quality roles within regulated industries, strong communication skills, and a Bachelor's or Master's Degree in engineering. This role contributes to patient safety and product effectiveness, with opportunities for professional development in a supportive environment.

Benefits

Culture of caring

Continuous learning and development

Work-life balance

High-trust organization

Qualifications

• At least 3 years of experience in a quality role within a regulated industry.
• Good understanding and practical application of medical device regulations.
• Experience with Design Controls, Risk Management techniques, and Auditing.

Responsibilities

• Lead review and approval of project documentation.
• Review and approve CSV documentation.
• Advise R&D regarding the established processes.
• Collaborate with engineering, product, and support teams.

Skills

Quality role experience

Medical device regulations knowledge

Design Controls

Risk Management techniques

Software V&V methodologies

Communication skills

Organizational skills

Education

Bachelor's or Master's Degree in engineering field

Job description

A global medical technology organization based in Poland is seeking a Quality Assurance Specialist to lead quality reviews and ensure compliance with regulatory standards. Candidates should have at least 3 years of experience in quality roles within regulated industries, strong communication skills, and a Bachelor's or Master's Degree in engineering. This role contributes to patient safety and product effectiveness, with opportunities for professional development in a supportive environment.