Quality Engineer
United Kingdom
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