Quality Engineer

We are currently seeking a dynamic Quality Engineer/ Product and Process Lifecycle Specialist to join our client's RAQA team. This pivotal role plays a crucial part in supporting their ongoing dedication to quality and operational efficiency. The successful candidate will be instrumental in providing critical quality engineering support to manufacturing and quality operations, leading significant product quality performance issues, New Product Introduction (NPI), or transformation processes.,

• Conducting QA reviews of design transfer.


• Establishing effective validation and validation planning activities.


• Identifying and validating processes according to established validation, design control, and regulatory submission plans.


• Establishing and maintaining effective product and process control plans and Failure Mode Effects Analysis (FMEA) through change control.


• Implementing effective Statistical Process Control (SPC) mechanisms where appropriate.


• Providing appropriate training as a result of validation, control planning, and FMEAs.


• Establishing product and process capability reporting and improvement plans.


• Reviewing submission, Nonconformance (NCP), and Corrective and Preventive Action (CAPA) reports for evidence of recurring product or process quality issues and establishing effective improvement plans.


• Reviewing significant product or process change submissions.


• Liaising with customers and suppliers on quality engineering activities.


• Reporting on product and process performance Key Performance Indicators (KPIs).
  
  Advanced degree or equivalent experience in a related field.


• Demonstrated at least 2-4 years' track record in a similar role, with extensive experience in quality management systems.


• Strong analytical skills and proficiency in data management and reporting.


• Excellent communication skills with fluency in English.


• Proficiency in Microsoft Office applications and experience with eQMS/ERP systems., Can you give an example of when you have had to identify and validate processes according to established validation, design control and regulatory submission plans?


Experience:

• Quality Assurance: 2 years (preferred)


• Medical Device/ IVD: 2 years (preferred)
  
  Job Types: Full-time, Permanent


Pay: £30,000.00-£45,000.00 per year

Benefits:

• Company pension


• Free parking


• On-site parking


Schedule:

• Monday to Friday


Supplemental pay types:

• Bonus scheme