Quality Systems Engineer

Quality Systems Engineer focuses on life sciences organisation is seeking a quality systems engineer to support.

What the role involves

• Life sciences organisation is seeking a Quality Systems Engineer to support.
• The position works closely with cross-functional teams including Production, Engineering, Regulatory Affairs, R&D, and Supply Chain to ensure compliance with ISO 13485 and FDA qual.
• Managing document control activities across the full document lifecycle.
• Administer electronic document management systems (eDMS/eQMS).
• Coordinating and facilitate change control processes and assessments.
• Process failure investigations using structured RCA methodologies (5-Why, Fishbone, FMEA, 8D etc.).

Skills and requirements

• Internal auditing experience.
• Risk management and validation knowledge.
• Experience supporting regulatory inspections and technical documentation.

Candidate fit

• technical judgement, safe working habits, careful diagnostics, and practical problem-solving