The Quality Improvement Lead drives operational quality performance across the Cardiff site, strengthening manufacturing reliability and right‑first‑time execution.
Responsibilities
- Deliver targeted quality initiatives across the site that improve reliability and right‑first‑time performance, aligned to site priorities and DBS principles.
- Partner with the wider Quality function and relevant stakeholders to identify quality issues and execute practical improvements.
- Track and trend nonconformances and customer complaints, driving focused actions to reduce recurrence and overall NC and complaint counts.
- Apply data and quality tools (SPC, capability, Pareto, trend analysis) to quantify performance, confirm root causes, and measure the impact of improvements.
- Own and deliver initiatives that reduce Cost of Quality by strengthening process controls, improving process robustness, and embedding sustainable standard work.
Qualifications
- Degree (or equivalent experience) in Engineering, Science, or a related discipline.
- 5+ years’ experience in ISO‑regulated / cGMP manufacturing (e.g., ISO 13485, pharmaceutical, FDA/MHRA regulated environments) with strong quality exposure.
- Works with a high level of autonomy to define a structured approach, manage competing priorities, and embed sustainable process improvements.
- Strong problem‑solving toolkit (RCA, 5Why, Fishbone, FMEA, etc.) and the ability to translate analysis into practical improvements.
- Strong stakeholder management skills, able to influence decisions and gain alignment across functions to implement change.
Preferred Qualifications
- Lean / DBS / Six Sigma training or certification, with experience applying CI methods to reduce defects and variation.
- Experience supporting external or internal audits/inspections (ISO, FDA, MHRA, notified bodies) and translating findings into effective, sustainable actions.
- Exposure to complex site improvements (new product introduction, process changes, or equipment/method improvements) within a regulated environment.
