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
Required skills
- Quality Procedures
- Pharmaceutical Industry
- lean manufacturing
- medical device
- FMEA, SPC, DOE, and Six Sigma/PPI,
- Quality Engineer,
- GMP, EU Regulations
- ISO 13485 standards
Reference: 52556592
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