Senior/Staff Quality Assurance Engineer (Qms & Iso)

Weare seeking an experienced and highly motivated Senior/Staff Quality Assurance Engineer to lead the development, implementation, and maintenance of our Quality Management System (QMS) in support of achieving and maintaining ISO 9001 certification . This role is ideal for someone who enjoys building quality systems from the ground up in a startup environment. The successful candidate will take ownership of QMS processes, drive continuous improvement initiatives, support customer and supplier quality activities, and establish a strong quality culture across the organization. Key Responsibilities · Lead the implementation, maintenance, and continual improvement of the Quality Management System (QMS)in accordance with ISO 9001 requirements. · Develop and maintain quality procedures, work instructions, forms, templates, and process documentation. · Establish document control and record management processes. · Coordinate internal audits, audit findings, CAPA activities, and management review meetings. · Monitor QMS effectiveness through quality metrics and KPIs. · Drive continual improvement initiatives and ensure compliance with ISO requirements. · Coordinate external certification and surveillance audits and support audit readiness across all departments. · Provide guidance and training to process owners on QMS requirements and best practices. Operations Supporting Role · Support Material Review Board (MRB)activities and disposition of non-conforming materials. · Develop and maintain quality records, quality metrics, and inspection documentation. · Support New Product Introduction(NPI) activities from a quality perspective. · Assist with product quality planning, risk assessments, and process improvements. · Coordinate product compliance documentation, including RoHS, REACH, IPC-1752A, Conflict Minerals, and other customer or regulatory requirements. · Support customer quality audits and quality questionnaires as required. · Perform other quality-related duties assigned by management. TheSuccessful Applicant · Bachelor’s Degree in Engineering, Quality, Manufacturing, or a related discipline. · Minimum 5 years of experience in Quality Engineering, Quality Systems, or Quality Management. · Proven experience implementing or maintaining an ISO 9001 Quality Management System . · Hands-on experience supporting ISO certification, internal audits, and external certification audits. · Strong knowledge of: o ISO 9001 o CAPA o Root Cause Analysis (8D, 5 Why, Fishbone) o Document Control o Internal Auditing o Continuous Improvement methodologies · Excellent documentation, communication, and project coordination skills. · Self-motivated with the ability to work independently in a fast-paced startup environment. Preferred Experience · ISO 9001 Internal Auditor or Lead Auditor certification. · Experience with electronic QMS or PLM systems (e.g., Propel, Arena, Agile). · Experience in semiconductor, electronics, or embedded systems industries. · Familiarity with product environmental compliance requirements (RoHS, REACH, IPC-1752A, Conflict Minerals). Key Competencies · Quality Management Systems (QMS) · ISO 9001 implementation and auditing · Process development and documentation · Continuous improvement mindset · Strong analytical and problem-solving skills · Cross-functional collaboration · Customer and supplier quality management · Excellent organizational and communication skills · Ability to build and improve quality processes in a startup environment