Quality Engineer

Selexa Life Sciences; Worcester; On-site; GBP 42,000 - 58,000; Full time

Job summary

Selexa Life Sciences is seeking a Quality Engineer to support quality assurance, product compliance and continuous improvement within a specialist medical device manufacturing environment.

The role focuses on supplier quality management, distributor oversight, NPD QA and design transfer QA, with an emphasis on maintaining and improving the QMS to align with regulatory requirements.

Qualifications

• Experience as a Quality Engineer in medical devices.
• Strong knowledge of QMS and ISO 13485.
• Proactive approach to quality and continuous improvement.

Responsibilities

• Maintain and improve QMS.
• Knowledge of supplier qualification and SQA processes.
• Understanding of design controls, risk management and product development processes.
• Lead investigations relating to non-conformances, deviations and CAPAs.
• Support change control activities and QA assessments.
• Support ISO 13485 compliance and regulatory requirements.
• Manage non-conformances, CAPAs and root cause investigations.
• Support internal audits, risk management and process improvements.
• Work collaboratively with engineering, manufacturing and regulatory teams.

Skills

Quality engineering

QMS knowledge

Medical devices

CAPA investigations

Risk management

Root cause analysis

Cross-functional collaboration

Job description

Selexa Life Sciences is supporting a leading Medical Device client in the search for a Quality Engineer to support quality assurance, product compliance and continuous improvement within a specialist medical device manufacturing environment.

Key Areas of Focus:

• Supplier Quality Management
• Distributor Qualification and Oversight
• NPD Quality Assurance
• Design Transfer QA

Key responsibilities:

• Maintain and improve Quality Management Systems (QMS)
• Knowledge of supplier qualification and SQA processes
• Understanding of design controls, risk management and product development processes
• Lead & support investigations relating to non-conformances, deviations and CAPAs
• Support change control activities and quality assurance assessments
• Support ISO 13485 compliance and regulatory requirements
• Manage non-conformances, CAPAs and root cause investigations
• Support internal audits, risk management and process improvements
• Work collaboratively with engineering, manufacturing and regulatory teams

The ideal candidate:

An experienced Quality Engineer with a background in medical devices, strong QMS knowledge and a proactive approach to quality and continuous improvement.