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 of the NB 1639 medical device.

• Handle daily QA responsibilities, encompassing the updating and management of documents under the MDD, MDR, and IVDR regulations.

• Administer the IF database.

• Collaborate on the development of generic scheme documents.

• Publish documentation on the SGS website.

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

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

• Address complaints, compliance inquiries, and appeals.

• Drive continual improvement initiatives.

• Oversee document control and record-keeping.

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

• Release revised quality management system documents in Bizzmine.

• Foster collaborative 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 training records.

• Provide technical support throughout the organization.

• Stay informed of SGS procedures, regulations, and guidance documents such as MDCG, along with external approval criteria.

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

• Achieve performance metrics for turnaround times on compliance matters, complaints, and appeals while ensuring efficient QMS operations.

⛳️ Requirements

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

• Highly detail-oriented.

• Strong organizational abilities.

• Capacity to manage one’s workload in accordance with priorities established by the global medical device quality manager.

• Quick adaptability and demonstrated flexibility.

• Team-oriented mindset.

• Proficient in writing clear and concise procedures.

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

• Fluent in both written and spoken English.

• Considerable 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 a similar discipline.

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

• Preferred: thorough 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 against recognized standards.

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

• Preferred: experience 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.

• Opportunities for personal growth, expertise development, and potential fulfillment.

• Remote work options available.