QARA Consultant

Job Title: Quality Assurance Consultant - Medical Device Remediation (12-Month Contract)

Location: Remote (Germany, Austria, or Poland DACH)

Duration: 12 Months (with potential for extension)

Industry: Medical Devices

About the Role:

We are seeking a highly experienced Quality Assurance Consultant to support a leading Medical Device client on a critical remediation project. This is a fully remote, 12-month contract role, open to candidates based in Germany, Austria, or Poland. You will play a key part in ensuring compliance with EU MDR and other regulatory requirements while supporting ongoing remediation and quality system enhancement activities.

Key Responsibilities:

• Support remediation efforts related to design history files (DHFs), technical documentation, and risk management files

• Conduct gap assessments and implement corrective actions to align with EU MDR and FDA QSR requirements

• Collaborate cross-functionally with Regulatory Affairs, R&D, and Quality Engineering teams

• Support audits, CAPA implementation, and document control updates

• Develop and update procedures and templates to ensure quality system compliance

• Assist in training internal teams on updated processes and compliance standards

Requirements:

• Bachelor's degree in Life Sciences, Engineering, or related field

• Minimum 5 years' experience in Quality Assurance within the Medical Device industry

• Proven experience in remediation projects, especially related to EU MDR

• Strong understanding of ISO 13485, EU MDR, FDA 21 CFR Part 820

• Excellent communication skills in English (German or Polish is a plus)

• Comfortable working independently in a remote, fast-paced environment