Quality Engineer

We are seeking an experienced Quality Engineer to support and drive quality performance within a regulated manufacturing environment. This role plays a key part in ensuring manufacturing processes, products, and quality systems meet internal standards, customer requirements, and applicable regulations.

Key Responsibilities:

• Lead investigations into manufacturing and product nonconformances, including root cause analysis and CAPA.
• Support and improve manufacturing process control using tools such as SPC, PFMEA, control plans, and process mapping.
• Work closely with Operations and Engineering to drive continuous improvement initiatives.
• Interface with customers and suppliers to resolve quality issues.
• Support Quality Management System activities including change control, documentation, MRB, and audits.
• Create and maintain quality procedures and work instructions.

• Experience as a Quality Engineer within a regulated manufacturing environment.
• Strong knowledge of quality systems such as ISO 9001 and/or ISO 13485.
• Confident problem-solver with experience in root cause analysis and CAPA.
• Strong communicator who works well across teams.