Quality Systems Engineer
Regal Technology Partners
Quality Systems Engineer
The Quality Systems Engineer is responsible for maintaining, improving, and ensuring compliance of the company's Quality Management System (QMS) in accordance with AS9100 and applicable regulatory requirements. This role leads internal audits, supports corrective and preventive actions (CAPA), and drives continuous improvement initiatives across the organization.
The Quality Systems Engineer works cross-functionally with operations, engineering, production, and leadership teams to strengthen quality processes, improve operational effectiveness, and promote a culture of quality awareness and accountability.
Key Responsibilities:
- Maintain and improve the company's Quality Management System in compliance with AS9100 standards and internal procedures.
- Ensure QMS documentation, procedures, and records are accurate, controlled, and updated as needed.
- Support company compliance with customer, regulatory, and certification requirements.
- Lead Corrective and Preventive Action (CAPA) reviews across the organization.
- Investigate root causes of quality issues and support implementation of corrective actions.
- Track CAPA effectiveness and ensure timely closure.
- Drive continuous improvement initiatives across departments.
- Develop, implement, and manage the Internal Audit Program.
- Conduct internal audits to AS9100 standards and company procedures.
- Coordinate audit activities including preparation, execution, reporting, and follow-up actions.
- Support external audits from certification bodies, customers, and regulatory agencies.
- Conduct 5S audits to ensure workplace organization and operational efficiency.
- Promote 5S methodology and continuous improvement within operational teams.
- Provide recommendations for process improvements and operational standardization.
- Oversee the equipment calibration program to ensure measurement tools remain compliant with required standards.
- Maintain calibration records and coordinate calibration schedules with internal teams or external vendors.
- Support the development and maintenance of the company's quality training program.
- Create and deliver quality awareness materials and training sessions, including quality videos and educational content.
- Promote engagement and awareness of quality policies and procedures across the organization.
- Support the preparation and development of management review materials, including quality metrics, audit results, and improvement initiatives.
- Monitor key quality performance indicators and provide analysis to leadership.
Qualifications:
- Bachelor's degree in Engineering, Quality, or related technical discipline (preferred).
- 6–8 years of experience working with Quality Management Systems, preferably within a manufacturing environment.
- Strong working knowledge of IPC-A-610, J-STD-001, AS9102, AS9100, and ISO 9001 standards.
Physical Requirements:
- Ability to sit, stand, walk, reach with hands and arms, and use hands to operate standard office and inspection equipment.
- Occasionally required to stoop, kneel, crouch, or crawl.
- Must be able to lift and/or move up to 25 pounds occasionally.
- Must be able to work in environments that include manufacturing floors, clean rooms, and test labs, with occasional exposure to machinery or moving parts.
$119.2k - $149k
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