At a Glance
- Tasks: Ensure compliance with medical device regulations and oversee quality across the supply chain.
- Company: Join an innovative MedTech organisation making a difference in healthcare.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Dynamic work environment with a focus on continuous improvement and career advancement.
- Why this job: Play a vital role in ensuring product quality and safety in the medical field.
- Qualifications: Experience in quality management systems and knowledge of medical device regulations.
The predicted salary is between 40000 - 50000 £ per year.
Aurora Lifesciences is partnered with an innovative MedTech organisation that is currently in search of its next critical hire. The Senior Supplier Quality Engineer will ensure that logistics, warehousing, storage, handling, and distribution activities comply with medical device regulations and quality standards, including ISO 13485, EU MDR 2017/745, FDA 21 CFR Part 820, and GDP. The Supplier Quality Engineer will provide quality oversight across the supply chain, from finished goods release through to customer delivery, supporting qualification audits, distribution controls, traceability, CAPA, risk management, validation, and continuous improvement.
Key Responsibilities
- The Supplier Quality Engineer will ensure logistics, warehousing, storage, handling, and distribution processes comply with ISO 13485, GDP, EU MDR, FDA 21 CFR Part 820, and internal QMS requirements.
- The Senior Supplier Quality Engineer will support and improve QMS processes relating to warehousing, logistics, distribution, and product quality.
- Act as quality SME for logistics and distribution processes during internal and external audits.
- Provide quality oversight for product storage, packaging, labelling, shipment, environmental controls, and sterile medical device handling.
- Review and approve shipping, transport validation, and related distribution documentation.
- Maintain product traceability, including batch, lot, and serialisation controls.
Supplier Quality Engineer employer: Aurora Life Sciences
Aurora Lifesciences is an exceptional employer, offering a dynamic work environment within the innovative MedTech sector. Employees benefit from a strong commitment to quality and compliance, alongside opportunities for professional growth through continuous improvement initiatives and involvement in critical projects. Located in a thriving area for medical technology, the company fosters a collaborative culture that values employee contributions and encourages career advancement.
