Quality Engineer – Compliance
vor 22 Stunden
- Manage and maintain the Quality Management System (QMS) in alignment with ISO/IEC 17025 and ISO 9001:2015 requirements.
- Support the transition of equipment, testing processes, and related documentation to a new facility, ensuring proper traceability and compliance throughout.
- Oversee the requalification and calibration of equipment post-relocation, ensuring records meet accreditation standards.
- Coordinate internal audits and assist with external accreditation and customer assessments tied to the transition.
- Ensure accurate documentation control, including updates to SOPs, quality records, and compliance manuals reflecting the new site environment.
- Drive continuous improvements, corrective actions, and incident tracking during both steady-state operations and the transition process.
- Monitor product quality during production, analyze test data, and implement corrective/preventive actions.
- Define, track, and report quality metrics and KPIs to leadership.
- Lead initiatives to improve processes using Lean, Six Sigma, and related tools.
- Provide training on ISO 17025 procedures and quality standards; serve as a subject matter expert for quality and compliance.
- Collaborate cross-functionally with operations, facilities, and regulatory teams to ensure a smooth and compliant transition.
- Bachelors Degree
- 5 years minimum of quality engineering experience in an electronics manufacturing environment.
- Strong knowledge of QMS, ISO/IEC 17025, testing methodologies, root cause analysis, and risk assessment.
- Experience managing QMS compliance and accreditation processes.
- Background in equipment calibration, testing traceability, and documentation control.
- Prior experience with facility transitions, equipment moves, or requalification projects a strong plus.
- Excellent communication and organizational skills, with the ability to coordinate across multiple functions.
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