Address
Form of work
SalaryQuality Engineer
Bath
£55,000 - £65,000
We are seeking a Quality Engineer with a good understanding of molecular biology.
The company is a healthcare technology company who are going through a time of rapid growth and is offering an opportunity to influence quality management system requirements and product standards. Your role will encompass diverse responsibilities, including non-conformance management, leading CAPA investigations, validating documentation, and supporting audits. Regular site visits to manufacturing facilities are integral to this role, contributing to quality enhancement aligned with our values.
Key Responsibilities:
- Execute process validation for existing and new products
- Ensure adherence to product quality requirements at contract manufacturers
- Lead root cause investigations, non-conformance management, and data trending
- Assess and lead CAPA investigations and activity closure
- Review and approve validation documentation
- Investigate and analyse complaint trends
- Provide support for internal and external audits
- Manage SCARs with manufacturers, ensuring timely closeout and reporting on corrective actions
- Develop and maintain risk management documentation, such as process FMEA
- Collaborate with Manufacturing team to maintain product consistency
- Ensure quality requirements are met as manufacturing scales and processes are optimised
- Analyse manufacturing performance, identify improvement opportunities, and assist in process mapping and waste identification
- Act as a key liaison with contract manufacturers for document control, design control, and CAPA management
Requirements:
- A good understanding of molecular biology
- Bachelor's degree in a relevant discipline or equivalent experience
- Comprehensive knowledge of Process Validation
- Experience in Risk Management, CAPA, and Non-Conformance Reporting
- Supplier corrective actions reporting
- Design Verification experience
- Material and process characterization
- Exposure to cGMP, FDA, and/or ISO 13485 environments
- Proficiency in root cause analysis
- Involvement in LEAN, BEX, or OPEX environments, including Kaizen or BPM events
- Ability to develop and analyse KPI data
- DFMEA & PFMEA experience
