Senior Quality Engineer — MedTech NPD & Compliance

STERIS; Bishop's Stortford; Presencial; GBP 50 000 - 65 000; Tempo integral

Resumo da oferta

STERIS is recruiting a Senior Quality Engineer in the UK to support new product development and maintain quality systems across manufacturing. You will work within the Medisafe team to ensure compliance with ISO13485 and regulatory requirements, leading quality activities and continuous improvement initiatives.

The role involves internal and external audits, CAPA handling, data analysis and cross-functional collaboration to uphold product safety and performance standards.

Qualificações

• Min 5 years working experience of ISO13485 or similar.
• Hands on engineering experience.
• Min 5 years working in manufacturing.
• Data analysis experience.
• LEAN knowledge.
• New product development.

Responsabilidades

• Provide quality support for new product development.
• Maintain complaint and CAPA processes.
• Report responsibilities of other quality team members.
• Implement, maintain and improve Quality Management Systems and processes per organisational objectives.
• Identify opportunities for improvements and implement them in line with objectives.
• Conduct internal and external audits as required.
• Represent the quality team on projects to ensure QMS compliance.
• Support relationships with customers and regulators from a quality viewpoint; uphold the organisation's integrity.

Conhecimentos

Problem solving & root cause

People management

Communication across levels

Workload management

Formação académica

Bachelor degree

Descrição da oferta de emprego

STERIS is recruiting a Senior Quality Engineer in the UK to support new product development and maintain quality systems across manufacturing. You will work within the Medisafe team to ensure compliance with ISO13485 and regulatory requirements, leading quality activities and continuous improvement initiatives.

The role involves internal and external audits, CAPA handling, data analysis and cross-functional collaboration to uphold product safety and performance standards.