At a Glance
- Tasks: Collaborate with engineers to ensure top-notch quality in life-changing medical devices.
- Company: Leading medical device manufacturer known for innovation and excellence.
- Benefits: 28 days holiday, health care, and a balanced 35-hour work week.
- Other info: Opportunity for hands-on work and professional growth in a supportive environment.
- Why this job: Join a dynamic team making a real difference in healthcare with cutting-edge products.
- Qualifications: Experience in quality assurance, root cause analysis, and regulatory standards.
The predicted salary is between 40000 - 55000 £ per year.
- Overview
- The Company
Our client is a leading medical device manufacturer with a strong reputation for being best in class.
You will be joining an innovative team that have created a life changing product in the market.
If you are a passionate, driven and dedicated Quality Engineer who has a passion for bringing safe medical devices to market this would be a great opportunity to join a dynamic team working with a cutting edge product.
Responsibilities
- Partner with Manufacturing Engineers to develop and qualify manufacturing processes.
- Review and approve design changes.
- Support or lead root cause analysis investigations for production-related or quality-related nonconformities and develop and aid in the implementation of corrective actions.
- Support elements of the Quality System such as NCRs, CAPAs and Complaints.
- Audit the manufacturing line to ensure compliance to governing procedures is being met.
- Key Skills / Qualifications
- Experience with nonconformances, investigations, root cause analysis, risk analysis and corrective/preventive actions.
- Must be familiar with 21CFR820, ISO 13485, and ISO14971 requirements.
- Must have strong project management and documentation skills.
- Must take initiative and have the ability to conduct hands-on work.
Benefits
- 28 days Holiday + Bank Holiday
- Health Care
- 35hr Per Week
- #J-18808-Ljbffr
Senior Quality Engineer employer: Aurora Lifesciences
Aurora Lifesciences is an exceptional employer, offering a collaborative work culture where innovation and quality are at the forefront of our medical device manufacturing team in South Yorkshire. We prioritise employee growth through continuous training and development opportunities, ensuring that our team members thrive in their careers while contributing to meaningful advancements in healthcare technology.
