Quality Engineer

Quality Engineer - Contract Role

Location: Client Medical Device Manufacturing Site
Shift: Primarily Day Shift (Flexibility Required for Occasional Evening Shifts)
Contract Type: Contract Position

Job Summary

The Quality Engineer will ensure that all products manufactured at the client’s medical device site comply with approved specifications and that all site activities adhere to current Good Manufacturing Practice (cGMP) and applicable regulatory requirements.

Working as part of the Quality Team, the successful candidate will support the achievement of quality objectives and ensure ongoing compliance with internal procedures and external regulatory standards.

Key Responsibilities

• Coordinate assigned elements of the Quality Management System (QMS), ensuring full compliance across site operations
• Participate in internal and external quality audits as required
• Support the investigation of customer complaints and implement effective corrective and preventive actions (CAPA)
• Manage day-to-day CAPA activities, ensuring timely initiation, investigation, and closure
• Monitor and report on Quality System performance metrics for management review
• Deliver quality-related training to site personnel as required
• Escalate quality system failures and support implementation of corrective actions and product containment
• Verify effectiveness of corrective and preventive actions
• Ensure compliance with all applicable regulatory requirements (e.g., ISO, FDA)
• Support validation activities across manufacturing processes
• Maintain accurate, complete, and compliant Quality System documentation
• Review lot/batch records and perform product release activities
• Inspect incoming materials and support supplier quality management
• Perform in-process and final product testing in line with approved specifications
• Participate in continuous improvement initiatives across quality, safety, and production systems
• Support risk management activities as required

Essential Requirements

• Degree in Engineering, Science, Quality, or a related discipline

Desirable Requirements

• Lean Six Sigma Green Belt or equivalent statistical knowledge
• Experience in injection moulding or tooling environments

Experience Required

• Minimum 2 years’ experience working within a Quality function in a highly regulated medical device or combination product manufacturing environment
• Working knowledge of quality system regulations such as ISO 13485, ISO 9000, and/or FDA 21 CFR Part 820
• Experience with key quality system elements such as CAPA, auditing, validation, and design controls

Key Skills & Competencies

• Strong attention to detail with a high level of accuracy
• Proven problem-solving and analytical skills
• Ability to adapt to changing processes and priorities
• Strong technical aptitude within a manufacturing environment
• Commitment to quality, compliance, and safety
• Ability to work independently with a high level of initiative

For a confidential conversation about the role please apply for the role or contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose