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 quality assurance tasks and documentation under the MDD, MDR, and IVDR regulations.

• Manage the IF database effectively.

• Collaborate on the creation and maintenance of generic scheme documents.

• Publish relevant documents on the SGS website.

• Support users of the Bizzmine quality management system.

• Address complaints, compliance inquiries, and appeals.

• Lead continual improvement initiatives.

• Oversee document control and record management.

• Conduct quality assurance evaluations on updated quality management system documents.

• Release updated quality management system documents within Bizzmine.

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

• Engage in professional development and maintain accurate training records.

• Provide technical assistance throughout the organization.

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

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

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

⛳️ Requirements

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

• Highly detail-oriented.

• Strong organizational capabilities.

• Ability to prioritize and manage one's own workload effectively.

• Capable of adapting swiftly and demonstrating flexibility.

• Ability to collaborate within a team setting.

• Proficient in writing clear and effective procedures.

• Good command of Microsoft Word, Excel, and Outlook.

• Fluent in written and spoken English.

• Significant experience in a role with quality assurance responsibilities.

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

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

• Preferred: thorough understanding of MDR, IVDR, and MDD regulations.

• Preferred: familiarity with ISO 17021-1:2015, ISO 13485, and ISO 9001 standards.

• Preferred: experience in the medical device sector.

• Preferred: auditing experience against recognized standards.

• Preferred: medical device training on MDD, MDR, IVDR, or ISO 13485.

• Preferred: qualification as a medical device auditor.

🏝️ Benefits

• Flexible work schedule and model.

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

• Work in a multinational environment alongside colleagues from various continents.

• Comprehensive benefits platform.

• Open, friendly, and supportive workplace culture.

• Opportunities for learning, growth, and achieving one's potential.

• Remote work options available.