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 By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose
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