Quality Engineer

QUALITY ENGINEER (DAYS)
 
Job Summary:
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.
• Ensure Quality System documentation is thorough, complete, and compliant.
• Ensure compliance with training requirements is maintained.
• Review lot records, ensuring documentation is compliant with requirements and completing lot release for shipment.
• Inspect incoming products and manage the supplier Quality relationship.
• Participation in continuous improvement programs to implement improvements in the quality, safety, environmental and production systems at the site.
• Complete in-process and final release product testing per the relevant approved specifications and procedures.
• Where required. Review batch records, ensuring documentation is compliant with requirements.
• Complete disposition decision for the batch.
• Participate in Risk Management activities as required.

 
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.

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.

 
For a confidential conversation about the role contact Owen Clancy at +353 86 060 2922 or oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose