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.

• Revise and uphold documentation in accordance with MDD, MDR, and IVDR regulations.

• Administer the IF database.

• Collaborate on the creation of generic scheme documents.

• Publish documents on the SGS website.

• Facilitate communication with users of the Bizzmine quality management system.

• Handle complaints, compliance inquiries, and appeals.

• Drive continual improvement initiatives.

• Supervise document control and record management.

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

• Release revised quality management system documents within Bizzmine.

• Cultivate professional relationships with Global Medical Device Certification, Competency, Technical, and Clinical Managers, along with other members of the Global Medical Device Team.

• Engage in professional development and maintain training documentation.

• Offer technical support throughout the business.

• Keep abreast of 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, 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.

• Capability to manage personal workload based on priorities set by the global medical device quality manager.

• Quick adaptability and demonstrated flexibility.

• Ability to collaborate effectively within a team.

• Proficient in writing clear procedures.

• Solid working 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 related field, such as pharmacy, bioengineering, nursing, or a comparable discipline.

• Valid work permit for the country of residence.

• Preferred: comprehensive understanding of MDR, IVDR, and MDD.

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

• Preferred: experience with medical devices.

• Preferred: auditing experience in accordance with recognized standards.

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

• Preferred: qualification as a medical device auditor.

🏝️ Benefits

• Flexible scheduling and work model.

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

• Comprehensive benefits platform.

• Multinational work environment with colleagues from various continents.

• Opportunities for learning, developing expertise, and reaching full potential.

• Support for employee development within the organization.