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Quality Assurance Engineer
3 months ago
Job Overview
The primary focus of this role is to enhance the 'cost of quality' objectives at our manufacturing facility through thorough, proactive analysis and enhancement of process efficiencies. This position is responsible for leading investigations related to critical quality issues, employing root-cause analysis to pinpoint and execute containment, corrective, and preventive measures.
Key Responsibilities
1. Conduct CAPA investigations;
2. Investigate quality complaints;
3. Lead Change Management Quality initiatives;
4. Perform Internal Audits in accordance with ISO13485, MDSAP, and relevant UK and EU standards;
5. Assess Product & Process Risks;
6. Validate and approve Product & Process protocols;
7. Generate and approve Product and Material specifications;
8. Assist in the creation of Technical File content;
9. Implement Lean Manufacturing principles such as 5S, OEE, Conversion Loss, and Right First Time;
10. Maintain and manage procedures, forms, and records relevant to this role;
11. Oversee CAPA management, Root Cause Analysis, Risk assessments, and effectiveness reviews;
12. Execute kaizen projects based on complaint trends, post-market surveillance, or departmental feedback;
13. Review FMEA, Control Plans, and CAPA to ensure Risk Priority Numbers are current and valid, with process controls integrated into the Risk Management database;
14. Complete Product & Process validations, ensuring all documentation is linked to relevant Technical Files and that site Validation Master Plans are upheld;
15. Manage Supplier Quality Assurance activities, including approvals and audits;
16. Support the application of Lean Management principles in both Quality and Operations;
17. Drive improvements in Cost of Quality metrics, including OEE, Conversion Loss, CAPA, and Complaint reduction.
The responsibilities outlined above are not exhaustive and may evolve. The job holder may be required to undertake additional duties within the overall scope and grading of the role as necessary to meet business needs.
Qualifications
Skills and Competencies
Exceptional written and verbal communication skills to facilitate kaizen project implementations. Strong problem-solving and troubleshooting abilities, with a knack for identifying root causes using 6σ tools. Proficient in Microsoft Office, enabling the creation of professional SOPs and WINs. A strong drive, passion, and determination to achieve successful outcomes. A positive attitude, enjoyment of teamwork, and eagerness to learn and grow. Ability to work effectively with and influence Operations personnel. Commitment to accountability and integrity in all actions.