QARA Consultant

EPM Scientific; Dortmund; Remote; EUR 60.000 - 90.000; Vollzeit

Zusammenfassung

A leading company in the Medical Device industry is seeking a Quality Assurance Consultant for a 12-month remote contract. The role involves ensuring compliance with EU MDR and supporting remediation projects, requiring a strong background in Quality Assurance and regulatory standards. Candidates should have at least 5 years of experience and a relevant degree, with excellent communication skills in English.

Qualifikationen

• Minimum 5 years' experience in Quality Assurance within the Medical Device industry.
• Proven experience in remediation projects related to EU MDR.
• Strong understanding of ISO 13485, EU MDR, FDA 21 CFR Part 820.

Aufgaben

• Support remediation efforts related to design history files and technical documentation.
• Conduct gap assessments and implement corrective actions.
• Collaborate cross-functionally with Regulatory Affairs and Quality Engineering teams.

Kenntnisse

Quality Assurance

Regulatory Compliance

Risk Management

Communication

Ausbildung

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

Jobbeschreibung

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