Quality Engineer – Medical Device Quality & Compliance

STERIS; Swindon; On-site; GBP 45,000 - 65,000; Full time

Job summary

STERIS AST is recruiting a Quality Engineer to strengthen our quality and regulatory functions. The role involves reviewing processing files for new products, ensuring release criteria are met, and maintaining calibration and records in line with QSR/cGMP expectations.

You will support internal audits, customer/regulatory audits, and drive continuous improvement through corrective actions, training, and documentation in a fast-paced manufacturing environment.

Qualifications

• Minimum 3 years professional experience in regulatory affairs, quality systems or related fields.
• Ability to read, write and communicate in English.
• Experience with internal auditing and compliance matters is preferred.

Responsibilities

• Performs review of processing files for new product or specification requirements to ensure processing parameters are met and approves product release.
• Reviews operating logs and calibration records to ensure timely, accurate documentation and compliance.
• Maintains and revises AST quality systems; writes deviations and responses; supports regulatory and customer audits.
• Develops corrective actions in response to deviations, complaints or audits and creates training materials.
• Prepares internal assessment reports and supports continuous improvement projects across the facility.
• Monitors quality data and implements improvement plans; participates in safety and regulatory compliance activities.

Skills

Regulatory affairs

Quality systems

Internal auditing

English proficiency

Analytical skills

Job description

STERIS AST is recruiting a Quality Engineer to strengthen our quality and regulatory functions. The role involves reviewing processing files for new products, ensuring release criteria are met, and maintaining calibration and records in line with QSR/cGMP expectations.

You will support internal audits, customer/regulatory audits, and drive continuous improvement through corrective actions, training, and documentation in a fast-paced manufacturing environment.