At a Glance
- Tasks: Ensure compliance with medical device regulations and oversee quality across the supply chain.
- Company: Join an innovative Medtech company 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 innovation.
- Why this job: Play a vital role in ensuring product quality and safety in the medical field.
- Qualifications: Experience in quality engineering and knowledge of medical device regulations.
The predicted salary is between 45000 - 55000 £ per year.
Aurora Lifesciences is partnered with an innovative Medtech who are currently in search of their 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 role 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.
- 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 where applicable.
- Monitor logistics providers, warehouse...
Senior Supplier Quality Engineer employer: Aurora Life Sciences
Aurora Lifesciences is an exceptional employer, offering a dynamic work environment where innovation meets compliance in the Medtech sector. With a strong commitment to employee development and a culture that prioritises quality and continuous improvement, team members are empowered to grow their skills while ensuring the highest standards in medical device logistics and distribution. Located in a vibrant area, employees benefit from a collaborative atmosphere and the opportunity to make a meaningful impact on healthcare outcomes.
