Quality Engineer
To support the overall quality team, assist the Quality Operations Manager in implementing and maintaining the Quality Management System.
Key Responsibilities:
* Ensure daily adherence to quality policies and procedures in accordance with the Quality Management System during production and release of finished parts.
* Interface with customers to realize customer satisfaction.
* Maintain production Good Manufacturing Practice (GMP) standards.
* Investigate root causes and implement effective corrective actions to prevent recurrence of customer and internal quality issues.
* Initiate and complete Corrective Action Preventive Action (CAPA) and engineering change requests as required.
* Initiate and complete non-conformance reports (NCRs) coordinating product/production-related NCRs to closure in a timely manner.
* Establish and monitor inspection standards, plans, frequencies, and test methods.
* Establish and maintain Failure Mode and Effects Analysis (FMEA).
* Prepare and update quality system documentation.
* SUPPORT customer and surveillance accreditation audits.
* Participate actively 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 but not essential.
* Contribute to the further development and continuous improvement of the quality management system.
* Support Operations area projects and initiatives.
* Train new or existing 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 disposition of on-hold material in a timely manner.
* Ensure correct storage of retained samples and maintenance of sample storage area.
* Ensure completion of all quality records per procedure and compliance with GDP.
* Adhere to incoming control requirements and support SCAR process when required.
* Audit experience is advantageous but not essential.
Minimum Qualifications:
* A relevant 3rd level qualification and/or equivalent quality experience, ideally in high-volume manufacturing.
Skills:
* Good communication and interpersonal skills.
* Ability to work as a team player and independently.
* Proactive and solutions-driven approach.