Quality Assurance Officer – 1 Year Maternity Cover

This is a fully remote position, open to applicants in Poland, +1 more country.

📋 Description

• Oversee the internal quality management system for the NB 1639 medical device.

• Handle daily QA responsibilities, including the updating and management of documents in accordance with MDD, MDR, and IVDR regulations.

• Administer the IF database.

• Collaborate on the development of generic scheme documents.

• Publish relevant documents on the SGS website.

• Maintain and support the Bizzmine quality management system, ensuring effective user communication.

• Address complaints, compliance inquiries, and appeals.

• Drive continual improvement initiatives.

• Manage document control processes and maintain records.

• Conduct quality assurance checks on revised quality management system documents.

• Release updated documents within the Bizzmine platform.

• Foster working relationships with Global Medical Device Certification, Competency, Technical, and Clinical Managers, as well as other members of the Global Medical Device Team.

• Engage in professional development and maintain relevant training documentation.

• Provide technical assistance throughout the organization.

• Stay informed about SGS procedures, regulations, guidance documents, and external approval criteria.

• Assist in the development and upkeep of combined scheme documents.

• Report directly to the Quality & Regulatory Manager in Business Assurance.

⛳️ Requirements

• Solid understanding of quality management systems, particularly in CAPA management, document control, and good documentation practices (GDP).

• Strong attention to detail.

• Excellent organizational abilities.

• Capability to manage one’s workload while considering priorities established by the global medical device quality manager.

• Quick adaptability and demonstrated flexibility.

• Team-oriented with the ability to collaborate effectively.

• Proficient in writing clear and concise procedures.

• Familiarity with MS Office tools (Word, Excel, Outlook).

• Proficient in written and spoken English.

• Extensive work experience in a role with QA responsibilities.

• Bachelor’s degree (or higher) in Biomedical Sciences or a related field, such as pharmacy, bioengineering, nursing, or similar disciplines.

• Valid work permit for the country of residence.

• Preferred qualifications: in-depth understanding of global medical device regulations including MDR, IVDR, and MDD.

• Preferred qualifications: knowledge of ISO 17021-1:2015, ISO 13485, and ISO 9001 standards.

• Preferred qualifications: experience with medical devices.

• Preferred qualifications: auditing experience against recognized standards.

• Preferred qualifications: medical device training related to MDD, MDR, IVDR, or ISO 13485.

• Preferred qualifications: experience as a medical device auditor.

🏝️ Benefits

• Flexible schedule and work model.

• Access to SGS University and Campus for continuous learning opportunities.

• Comprehensive benefits platform.

• Open, friendly, and supportive workplace culture.

• Opportunities for learning, skill enhancement, and realizing potential.

• Multinational work environment.

• Long-term support for employee development.