QUALITY ENGINEER Role To ensure that products manufactured at the site complies with approved specifications and that activities at the site comply with current good manufacturing practice and Regulatory Agency requirements.
To work as a member of the Quality Team to ensure that Quality goals and objectives are achieved.
Ensure that all actions comply with current good manufacturing practice.
Key Responsibilities: Coordinating appropriate assigned elements of the Quality System, ensuring full compliance by all relevant plant personnel with its requirements.
Audit the quality system with other personnel where required.
Assist in the investigation and coordination of customer complaints and assess the need for implementation of effective corrective or preventive actions.
Manage day-to-day CAPA requirements by ensuring timely and effective initiation, investigation, correction and corrective actions.
Measure performance of the Quality System and provide metrics, for inclusion in the management review, monthly reports etc.
Ensure all plant personnel are fully aware of quality requirements (where relevant) by providing the necessary training.
Ensure Management is kept informed of all system failures to ensure corrective/preventive action and product containment is taken where necessary.
Verification of effectiveness of corrective/preventive actions arising out of product process and quality system non-compliance.
Ensure implementation and compliance with relevant Regulator requirements.
Assist in the performance of validation activities at the site.
Experience Required 2 years plus experience in the day-to-day operation of the quality system in a highly regulated combination product/device manufacturing environment.
Minimum 2 years working knowledge of quality systems regulations (ISO13485/ISO9000; CFR 21 Part 820) or individual elements within the regulations such as process validation, design controls, CAPA, auditing, etc., is desirable.
Experience in an injection moulding or tooling environment is desirable.
Essential Requirements Degree in an Engineering, Science, Quality or other discipline Desired Requirements A Green Belt qualified or demonstrated knowledge of statistics in an industrial environment is desirable.
EHS Requirements Comply with the EHS policy and procedures and demonstrate EHS best practices in all work activities.
Continually be conscious of your own safety and that of others, always complying with safety notices and barriers.
Report any EHS incidents and/or Near Misses (unsafe acts and conditions) immediately to your supervisor and always raise the event in EHS system.
Support a culture of EHS excellence by recognizing and submitting opportunities for EHS improvement on EHS system.
Attend all required EHS training and medical surveillance programs.
Wear PPE as required.
For further information please forward your CV Skills: Quality Systems Management Validation