Senior Quality Engineer

The Role: You’ll support manufacturing quality by monitoring production performance, analysing quality data, leading root cause investigations, and implementing corrective actions that keep product within specification and in line with regulatory requirements. The role sits at the centre of the site, partnering with Operations, Manufacturing Engineering, Regulatory, Supply Chain, and site leadership to reduce quality risk and drive continuous improvement.

What you’ll be doing: Analysing quality and production data to identify trends, track KPIs, and deliver data-driven improvements that reduce defects and improve efficiency using lean principles Leading root cause investigations using structured problem-solving methodologies (CAPA, 8D, Fishbone, 5 Whys) to resolve issues and prevent recurrence Monitoring shop floor processes for compliance with specifications, control plans, and standard work instructions Participating in internal audits and layered process audits (LPA), supporting external and customer audits, and maintaining accurate quality documentation (SOPs, inspection records) Acting as the primary quality liaison between Manufacturing, Engineering, Supply Chain, and customers

What we’re looking for: Bachelor’s degree in engineering, science, or a related technical discipline (preferred) 5+ years in Quality Engineering or Quality Systems within a regulated manufacturing environment - life sciences, biotech, pharmaceutical, medical device, or comparable regulated industry A detail‑oriented, analytical problem solver with genuine interest in manufacturing quality and continuous improvement Exposure to any of the following is welcomed: contamination control, sterility assurance, SPC, Lean methodologies, or material science within a regulated environment Comfortable in a fast‑paced production environment working cross‑functionally

Nice to have: Familiarity with global regulatory expectations (FDA, ISO, GMP)

The Role: You’ll support manufacturing quality by monitoring production performance, analysing quality data, leading root cause investigations, and implementing corrective actions that keep product within specification and in line with regulatory requirements. The role sits at the centre of the site, partnering with Operations, Manufacturing Engineering, Regulatory, Supply Chain, and site leadership to reduce quality risk and drive continuous improvement.

What you’ll be doing: Analysing quality and production data to identify trends, track KPIs, and deliver data-driven improvements that reduce defects and improve efficiency using lean principles Leading root cause investigations using structured problem-solving methodologies (CAPA, 8D, Fishbone, 5 Whys) to resolve issues and prevent recurrence Monitoring shop floor processes for compliance with specifications, control plans, and standard work instructions Participating in internal audits and layered process audits (LPA), supporting external and customer audits, and maintaining accurate quality documentation (SOPs, inspection records)

What we’re looking for: Bachelor’s degree in engineering, science, or a related technical discipline (preferred) 5+ years in Quality Engineering or Quality Systems within a regulated manufacturing environment - life sciences, biotech, pharmaceutical, medical device, or comparable regulated industry A detail‑oriented, analytical problem solver with genuine interest in manufacturing quality and continuous improvement Exposure to any of the following is welcomed: contamination control, sterility assurance, SPC, Lean methodologies, or material science within a regulated environment Comfortable in a fast‑paced production environment working cross‑functionally

Nice to have: Familiarity with global regulatory expectations (FDA, ISO, GMP)

Desired Skills and Experience: Medical Device