Quality Assurance Engineer - CAPA & Compliance

Align Technology, Inc.; Polska; On-site; PLN 120,000 - 180,000; Full time

Job summary

A leading medical device company in Poland is looking for a Quality Assurance Engineer to oversee quality assurance and control activities. This role is critical in supporting various manufacturing departments and ensuring compliance with regulations. The ideal candidate will have at least 3 years of experience in a quality role, especially in regulated areas, and must be fluent in English and Polish. This position offers a comprehensive benefits package, including medical care and an annual bonus based on performance.

Benefits

Private medical care

Multisport card

Private life insurance

Social fund

Meal subsidies

Discounts on company products

Qualifications

• 3+ years of experience in a quality/compliance role, preferably in medical devices.
• Strong understanding of quality system regulations for medical devices.

Responsibilities

• Ensure compliance with all quality assurance and control activities.
• Support internal and cross-functional teams in quality improvement efforts.
• Conduct audits and participate in external inspections.

Skills

Problem solving

Production processes knowledge

Statistics (Minitab)

ISO 13485 knowledge

MS Office skills

Goal achieving focus

Education

Bachelor degree in chemistry, engineering, or quality

Post graduate studies related to Quality Management

Job description

A leading medical device company in Poland is looking for a Quality Assurance Engineer to oversee quality assurance and control activities. This role is critical in supporting various manufacturing departments and ensuring compliance with regulations. The ideal candidate will have at least 3 years of experience in a quality role, especially in regulated areas, and must be fluent in English and Polish. This position offers a comprehensive benefits package, including medical care and an annual bonus based on performance.