Quality Engineer Position
To assist the Quality Operations Manager in implementing and maintaining a quality management system, supporting overall quality initiatives.
Key Responsibilities:
* Monitor production and finished parts release to ensure adherence to quality policies and procedures.
* Interface with customers to achieve satisfaction.
* Maintain production GMP standards.
* Investigate root causes and implement corrective actions for customer and internal quality issues.
* Initiate and complete CAPA actions as required.
* Implement and finalize engineering change requests and actions.
* Complete non-conformance reports (NCRs) and coordinate product/production-related NCRs to timely closure.
* Establish and monitor inspection standards, plans, frequencies, and test methods.
* Develop 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 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 such as Drawings, Purchase Specifications, Quality Agreements, etc.
* Disposition on-hold material in a timely manner.
* Ensure retained samples are stored correctly and the sample storage area is maintained.
* Comply with all quality records per procedure and GDP requirements.
* Adhere to incoming control requirements and support the SCAR process when needed.
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.