Your Role

The Quality Assurance Specialist will be part of the Quality Assurance team in Riese and will be responsible for implementing and maintaining the Company’s Quality Management System (QMS) in compliance with applicable industry standards.

Tasks & Responsibilities

- Supports the organization in maintaining, improving and implementation of the Quality Management System.
- Supports the organization in controlling the cases in the CAPA Management System regarding
- Documentation quality
- Time deadlines
- Efficacy of Corrective and Preventive Actions

- Supports the operation of the CAPA Management System and understands the meaning of Non-Conformance handling processes such as audit findings, non-conformance, complaints, investigations and reportable incidents.
- Performs trainings of users in CAPA processes.
- Acts as interface between users of the CAPA Management Tool (super user), determines further developments of the CAPA Management Tool.
- Supports process owners in updating and improving the processes of the Quality Management System.
- Prepares and executes internal audits.
- Takes part during audits/inspections of Notified bodies or authorities.
- Supports the Business Units and plants in quality and regulatory questions.

Your Profile

Skills & Competencies

- Directives,



regulations and standards for medical devices quality systems: MDR 2017/745, EN ISO 13485, EN ISO 9001, EN ISO 14971, 21CFR Part 820 Quality System Regulation; Part 803 Medical Device Reporting; Part 806 Medical Device Corrections and Removals; Part 821 Medical Device Tracking etc.
- Excellent English language skills (Advanced C1).
- Strong team work skills.
- Hands on mentality.
- Flexibility, reliability, mediation skills, and a strong sense of responsibility.

Required Experience

- Previous experience in a similar role is prerequisite, particularly in quality management systems for medical devices and/or other regulated industries.
- 5 years of experience in an international acting company.

Required Education

- Bachelor’s degree in or another similar scientific discipline.

Our Offer

- Work in an international, fast-growing industry that makes a real impact on healthcare and pharmaceutical industry.
- Be part of an innovative and open-minded team.
- Join a company with a strong reputation and long-standing expertise in cleaning and disinfection solutions.
- We offer a people-focused work environment, with dedicated benefits and welfare initiatives.

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📌 Quality Assurance Specialist (Riese Pio X)
🏢 Steelcobelimed
📍 Riese Pio X