Quality Assurance Officer – 1 year maternity cover

🔥 6 minutes ago

🇵🇱 Poland – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 12%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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SGS

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1878

💼 Consulting

🏥 Healthcare

🍽️ Food & Beverage

Consulting • Healthcare • Food & Beverage

SGS is the world's leading Testing, Inspection, and Certification (TIC) company, providing a comprehensive range of services designed to assure quality and integrity across various sectors. SGS is focused on sustainability, offering climate action services and an all-encompassing ESG portfolio under its IMPACT NOW suite. The company has ambitious targets for growth by 2027, driven by its strategy to address global megatrends. SGS operates globally, providing business assurance, connectivity and products, digital trust, health and nutrition, and solutions for industries and the environment.

📋 Description

• Maintain the NB 1639 medical device internal quality management system • Manage daily QA tasks, including updating and maintaining documents under MDD, MDR, and IVDR schemes • Manage the IF database • Collaborate on generic scheme documents • Publish documents on the SGS website • Manage Bizzmine quality management system user communication and maintenance • Report to the Quality & Regulatory Manager, Business Assurance • Manage complaints, compliance queries, and appeals • Manage continual improvement • Manage document control and records • Perform quality assurance checks on updated quality management system documents • Release updated quality management system documents in Bizzmine • Build working relationships with Global Medical Device Certification, Competency, Technical, and Clinical Managers and other Global Medical Device Team members • Undertake professional development and maintain training records • Provide technical support across the business • Maintain knowledge of SGS procedures, regulations, guidance documents such as MDCG, and external approval criteria • Support development and maintenance of combined scheme documents • Meet performance indicators for turnaround time on compliance issues, complaints, and appeals and efficient QMS operation

🎯 Requirements

• Good working knowledge of quality management systems, including CAPA management, document control, and good documentation practices (GDP) • Detail oriented • Strong organisational skills • Ability to organise own workload considering priorities set by the global medical device quality manager • Ability to adapt quickly and demonstrate flexibility • Ability to work in a team • Ability to write clear procedures • Good working knowledge of MS Office tools, including Word, Excel, and Outlook • Fluent written and spoken English • Significant work experience in a position with QA responsibility • Bachelor’s degree or higher in Biomedical Sciences or a similar field, such as pharmacy, bioengineering, nursing, or a related discipline • Valid work permit for the candidate's country of residency • Nice to have: detailed understanding of MDR, IVDR, and MDD • Nice to have: knowledge of ISO 17021-1:2015, ISO 13485, and ISO 9001 • Nice to have: experience working with medical devices • Nice to have: auditing experience against recognised standards • Nice to have: medical device training on MDD, MDR, IVDR, or ISO 13485 • Nice to have: medical device auditor

🏖️ Benefits

• Flexible schedule and work model • Access to SGS University and Campus for continuous learning options • Comprehensive benefits platform • Multinational environment • Opportunities to learn, grow expertise, and fulfill potential • Remote work model