Quality Assurance Specialist

About the role

The Quality Assurance Specialist will join the QA team in Riese, supporting the implementation and maintenance of the company’s Quality Management System (QMS) in line with medical‑device regulations.

Key responsibilities

• Support the organization in maintaining, improving and implementing the QMS.
• Manage the CAPA Management System, including case control, documentation quality, deadlines and effectiveness of corrective and preventive actions.
• Handle non‑conformance processes such as audit findings, complaints, investigations and reportable incidents.
• Deliver training on CAPA processes and act as super‑user interface for the CAPA tool.
• Assist process owners in updating and enhancing QMS procedures.
• Prepare and conduct internal audits and participate in external audits/inspections by notified bodies or authorities.
• Provide quality and regulatory support to business units and plants.

Required profile

• In‑depth knowledge of medical‑device quality regulations (MDR 2017/745, EN ISO 13485, EN ISO 9001, EN ISO 14971, 21 CFR Parts 820, 803, 806, 821).
• Advanced English proficiency (C1 level) and strong teamwork orientation.
• Hands‑on mentality, flexibility, reliability and a strong sense of responsibility.
• Minimum 5 years of experience in quality management for medical devices or other regulated industries within an international company.
• Bachelor’s degree in a scientific discipline or a related field.

Required skills

• MDR 2017/745
• EN ISO 13485
• EN ISO 9001
• EN ISO 14971
• 21CFR Part 820
• 21CFR Part 803
• 21CFR Part 806
• 21CFR Part 821
• CAPA Management System

What we offer

• Opportunity to work in an international, fast‑growing industry impacting healthcare and pharmaceuticals.
• Collaboration with an innovative and open‑minded team.
• Employment with a company renowned for cleaning and disinfection solutions.
• People‑focused work environment with dedicated benefits and welfare initiatives.