
Product Manufacturing Engineer (Quality Focused)
- Blackburn, Lancashire
- £40,000-45,000 per year
- Permanent
- Full-time
- Support quality compliance across product manufacturing activities, ensuring adherence to ISO 13485, ISO 14971 and customer requirements
- Work closely with the Quality department to manage supplier documentation, goods-in checks and audit readiness
- Ensure robust quality documentation is in place, including risk assessments, validation records and process controls
- Contribute to new product introduction (NPI) projects, ensuring quality standards are maintained during transfer to manufacturing
- Provide hands-on engineering support for equipment, process validation and production activities as required
- Act as a link between Quality and Manufacturing to embed compliance within everyday engineering practices
- Support continuous improvement and problem-solving initiatives across the production process
- Experience as a Quality Engineer (or similar) within the medical device sector or another highly regulated environment
- Strong knowledge of ISO 13485 and ISO 14971 standards and their application
- Understanding of the full product lifecycle, including goods-in, supplier documentation and final product release
- Strong understanding of manufacturing quality operations and supplier quality assurance
- Excellent documentation skills with a high level of accuracy and attention to detail
- Strong organisational and communication skills, able to collaborate effectively across departments
- Exposure to manufacturing or process engineering activities in a regulated environment
- Knowledge of validation processes, process controls and statistical methods
- Experience with new product introduction (NPI) and design transfer into manufacturing
- Familiarity with Lean or continuous improvement tools