Junior Quality Engineer

About the role

A Junior Quality Engineer supports daily activities to maintain the quality management system, including incoming inspection, calibration, training, complaint handling, and supplier quality. This role ensures compliance with quality standards, processes, and procedures while participating in cross-functional projects for quality and process improvement. The position also helps maintain regulatory compliance with FDA CFR 820, ISO 13485:2016, MDSAP, and EU Medical Device Regulations (MDR).

Responsibilities

• Ensure exceptional service for internal customers.
• Follow all procedures (SOPs) and documentation related to the Quality Management System to maintain compliance with all standards.
• Support the development, revision, and maintenance of procedures, documentation, and standards (e.g., incoming inspection, training, calibration) to ensure best practices and compliance.
• Assist in resolving quality issues related to non-conformance reports, cell shutdowns, customer complaints, process performance, and product performance.
• Support complaint investigations and documentation activities under the guidance of senior quality personnel, adhering to medical device regulations (FDA 21 CFR Part 820 and ISO 13485:2016) to drive process and product improvements.
• Assist in implementing process improvements using problem-solving techniques such as Problem-Solving Process (PSP), Variation Reduction (VRK), Value Stream Mapping (VSM), Transactional Process Improvement (TPI), and Lean/Six Sigma.
• Assist in the development, review, and approval of process and equipment validation/qualifications (IQ, OQ, PQ).
• Lead and/or support CAPA (Corrective and Preventive Actions) investigations and related actions.
• Ensure training support and effectiveness for multiple functions throughout the organization.
• Partner with functional teams to maintain the QMS training program per regulatory requirements.
• Assist in reporting the effectiveness of the Quality Management System.
• Provide support for internal and external audits and inspections.
• Assist in ensuring department goals and objectives are met.
• Report the status of the Quality Management System and related issues regularly to the Sr. QA Engineer and/or Quality Assurance Manager.
• Perform other duties as assigned by the Quality Assurance Manager.