Quality Engineer

The Quality Engineer role reports directly to the Quality Manager, overseeing manufacturing.

processes, methods, equipment, and quality systems to ensure compliance.

Qualifications and experience

• Bachelor’s degree in a science-related field required, preferably with quality assurance experience in medical device or pharmaceutical manufacturing.
• Proficiency in process control and statistical techniques essential.
• Prior experience with medical devices, GMP, EU Regulations, or ISO 13485 standards highly desirable.
• Demonstrated knowledge of compliance, quality standards, and scientific principles necessary.
• Proficiency in quality-related methodologies like structured problem solving, FMEA, SPC, DOE, and Six Sigma/PPI required.

Duties:

• Develop and maintain quality documentation and SOPs in line with industry and regulatory standards.
• Enhance systems and processes proactively to meet standards.
• Collaborate with Operations to enforce quality procedures and standards, implementing necessary changes.
• Establish controls and inspection points with Operations leadership to identify and correct nonconforming materials and products.
• Analyse issues, conduct statistical analysis, and generate reports for senior management.
• Provide guidance for failure investigations, validation protocols, and in-process controls.
• Facilitate resolution of process issues and quality workshops across departments.
• Collaborate with various teams to improve product quality and reduce costs.
• Drive productivity improvements through quality management.
• Lead quality-related corrective/preventive actions within Operations.
• Ensure alignment with policies, codes, and safety requirements.
• Analyse trends and implement corrective actions for processes and products.

We can only accept applicants who are living in the UK and eligible to work without restrictions.

Skills: lean manufacturing, FMEA, SPC, DOE, and Six Sigma/PPI, Quality Engineer,

software tools, medical device, Pharmaceutical

GMP, EU Regulations, or ISO 13485 standards