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