Location: Slough             

Industry: Medical Devices

Job Title: Senior Quality Systems Engineer

Job Type: Permanent – 100% Site Based

Salary: Up to £48k

We are a market leading Medical Device company, who, due to our exceptional continued growth, have an exciting opportunity for a Quality Systems Engineer to join our highly motivated team.

As our new Quality Systems Engineer, you will be responsible for:

• The Implementation, Management and Continual Improvement of the Quality Management System
• Act as Risk Management Lead, being the subject matter expert for Risk Management with the Quality System and effectively maintaining and implementing a Risk Management Process.
• Writing, reviewing, executing and maintaining validation documents including Site Validation Master Plan, Validation policies and processes and Equipment and Software Validation.
• Conducting internal and supplier audits

For our new Quality Systems Engineer to be successful you will need:

• An in-depth working knowledge of ISO 13485
• ISO 13485 Lead Auditor Qualified
• Software/Process Validation skills and knowledge
• Working knowledge of ISO 14971 and experience generating and maintaining Risk Management files
• Proficient in concepts of statistics, sampling plans and statistical analysis

Desirable attributes for a Quality Systems Engineer

• Educated to a degree level or equivalent in Life Science/Engineering discipline
• Experience in auditing to Medical Device standards and regulations
• Ability to work under minimal supervision

This is an excellent opportunity for a Quality Systems Engineer to join a progressive and innovative company with a passion for helping you to develop.

If you have the necessary skills and experience to be successful in this role, please click “Apply Now” or contact Chloe Halls on 01189 239 233 to discuss further.