Description:
PE Global is currently recruiting for a Quality Engineer on behalf of a leading medical device company. This 18-month contract role will involve ensuring products comply with approved specifications and current good manufacturing practice.
Key Responsibilities:
* Coordinating quality system elements to ensure full compliance with requirements.
* Auditing the quality system with other personnel where required.
* Assisting in customer complaint investigations and implementing corrective or preventive actions.
* Managing day-to-day CAPA requirements, ensuring timely initiation, investigation, correction, and implementation of corrective actions.
* Measuring quality system performance and providing metrics for management review and reports.
* Providing necessary training to plant personnel on quality requirements.
* Ensuring management is informed of system failures and taking corrective/preventive action as necessary.
* Verifying effectiveness of corrective/preventive actions arising from product process and quality system non-compliance.
* Ensuring compliance with relevant regulator requirements.
* Assisting in validation activities at the site.
* Maintaining quality system documentation completeness and compliance.
* Ensuring compliance with training requirements.
* Reviewing lot records and completing lot release for shipment.
* Inspecting incoming products and managing supplier quality relationships.
* Participating in continuous improvement programs to enhance quality, safety, environmental, and production systems.
* Completing in-process and final release product testing per approved specifications and procedures.
Requirements:
* Degree in an Engineering, Science, Quality, or other discipline.
* Green Belt qualification or demonstrated knowledge of statistics in an industrial environment is desirable.
* 4-6 years plus experience in the day-to-day operation of the quality system in a highly regulated combination product/device manufacturing environment.
* Minimum 4-6 years working knowledge of quality systems regulations (ISO13485/ISO9000; CFR 21 Part 820) or individual elements within the regulations.