Quality Assurance Officer – 1 Year Maternity Cover

This is a fully remote position, open to applicants in Poland.

📋 Description

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

• Handle daily quality assurance tasks, which include updating and maintaining documentation in accordance with MDD, MDR, and IVDR regulations.

• Administer the IF database.

• Collaborate on documents related to generic schemes.

• Publish documents on the SGS website.

• Manage user communication and maintenance of the Bizzmine quality management system.

• Address complaints, compliance inquiries, and appeals.

• Oversee continual improvement processes.

• Control documents and maintain records.

• Execute quality assurance checks on updated documentation within the quality management system.

• Release updated quality management system documents via Bizzmine.

• Establish strong working relationships with Global Medical Device Certification, Competency, Technical, and Clinical Managers, along with other members of the global medical device team.

• Pursue professional development and keep accurate training records.

• Offer technical support throughout the business.

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

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

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

⛳️ Requirements

• Strong understanding of quality management systems, including CAPA management, document control, and good documentation practices (GDP).

• Highly detail-oriented.

• Excellent organizational skills.

• Capable of managing personal workload based on priorities established by the global medical device quality manager.

• Quick adaptability and demonstrated flexibility.

• Effective team player.

• Proficient in writing clear and concise procedures.

• Good knowledge of MS Office applications, including Word, Excel, and Outlook.

• Fluent in written and spoken English.

• Extensive experience in a role with QA responsibilities.

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

• Valid work permit for the country of residence of the candidate.

• Nice to have: in-depth understanding of MDR, IVDR, and MDD.

• Nice to have: familiarity with ISO 17021-1:2015, ISO 13485, and ISO 9001.

• Nice to have: experience in the medical devices sector.

• Nice to have: auditing experience against recognized standards.

• Nice to have: medical device training related to MDD, MDR, IVDR, or ISO 13485.

• Nice to have: experience as a medical device auditor.

🏝️ Benefits

• Flexible scheduling and work arrangements.

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

• Comprehensive benefits package.

• Multinational workplace with colleagues from various continents.

• Support for employee growth and opportunities to enhance skills and reach potential.

• Open, friendly, and supportive company culture.

• Teamwork-centric environment.

• Diversity and opportunities for professional advancement within the organization.