Job Description:
To assist the Quality Operations Manager in implementing a Quality Management System and supporting the overall quality team.
* Monitor finished parts production and release to ensure adherence to quality policies and procedures daily, according to the Quality Management System.
* Interface with customers to achieve customer satisfaction.
* Maintain production GMP standards.
* Investigate root causes and implement effective corrective actions to prevent recurrence of customer and internal quality issues.
* Initiate and complete CAPA actions as required.
* Initiate and complete engineering change requests and actions as required.
* Initiate and complete non-conformance reports (NCRs) as required, coordinating product/production-related NCRs to closure in a timely manner.
* Establish and monitor inspection standards, plans, frequencies, and test methods.
* Establish and maintain FMEAs.
* Prepare and update quality system documentation.
* Support customer and surveillance accreditation audits.
* Participate in quality planning and new product introduction from a quality perspective.
* Develop strong links with customer organizations and other project stakeholders.
* Validation experience is advantageous (not essential).
* Contribute to the development and continuous improvement of the quality management system.
* Support Operations area projects and initiatives.
* Train personnel on quality procedures and documentation; ensure production personnel are trained for their tasks and that procedures are in place.
* Understand customer documents, i.e., drawings, purchase specifications, quality agreements, etc.
* Ensure on-hold material is dispositioned and actioned in a timely manner.
* Ensure retained samples are stored correctly and the sample storage area is maintained.
* Ensure all quality records are completed per procedure and comply with GDP.
* Adhere to incoming control requirements and support the SCAR process when required.
* Audit experience is advantageous (not essential).
Requirements:
Applicants should hold a relevant 3rd level qualification and/or equivalent quality experience, ideally in high-volume manufacturing.
* Good communication and interpersonal skills.
* Ability to work as a team player and independently.
* Proactive and solutions-driven approach.