Job Overview
We are seeking a Quality Assurance Specialist to join our team. This is an 18-month contract opportunity with a leading medical device manufacturer in the Connaught region.
Main Responsibilities:
* Coverage of assigned elements of the quality system to ensure full compliance by relevant plant personnel with its requirements.
* Audit and inspection of the quality system as required.
* Support in investigating and coordinating customer complaints and implementing effective corrective or preventive actions.
* Ensure timely initiation, investigation, correction and corrective actions for day-to-day CAPA requirements.
* Presentation of metrics on the performance of the Quality System for inclusion in the management review and monthly reports.
* Training of all plant personnel on quality requirements where necessary.
* Notification to management of all system failures to ensure prompt corrective/preventive action and product containment if needed.
* Verification of effectiveness of corrective/preventive actions arising from product process and quality system non-compliance.
* Maintenance of implementation and compliance with relevant Regulator requirements.
* Participation in validation activities at the site.
* Review and completeness of Quality System documentation.
* Maintenance of training records and compliance.
* Review of lot records to ensure documentation complies with requirements and complete lot release for shipment.
* Inspection of incoming products and management of supplier Quality relationship.
* Participation in continuous improvement programs for improvements in quality, safety, environmental, and production systems.
* Product testing in accordance with approved specifications and procedures.
* Review of batch records to ensure documentation is compliant with requirements.
* Disposition decision for batches.
* Support in Risk Management activities as needed.
Key Skills & Qualifications:
* Strong understanding of quality management principles and regulatory requirements.
* Excellent communication and interpersonal skills.
* Ability to work effectively in a team environment.
* Proficiency in MS Office applications.
* Familiarity with quality management software.
What We Offer:
* A challenging and rewarding role in a dynamic industry.
* Ongoing training and professional development opportunities.
* A collaborative and supportive work environment.