Senior Quality Engineer
- Develop, implement, and maintain the Quality Management System (QMS) in alignment with ISO 9001 standards for hardware product design and development processes.
- Collaborate with cross-functional teams including design, engineering, production, and operations to ensure quality standards are integrated throughout the product lifecycle.
- Conduct internal audits, risk assessments, and management reviews to ensure compliance with ISO 9001 and continuous improvement of the QMS.
- Lead and coordinate quality-related training programs for staff to increase awareness and ensure adherence to quality processes and standards.
- Analyze data and metrics related to product quality, troubleshoot issues, and implement corrective actions as necessary.
- Facilitate quality improvement projects and initiatives, employing methodologies such as Six Sigma and Lean principles to enhance product quality and operational efficiency.
- Act as the primary point of contact for any ISO 9001-related inquiries and audits by external bodies and regulatory agencies.
- Maintain accurate documentation and records related to quality activities, audits, and compliance assessments.
- Stay current with industry trends, best practices, and updates related to ISO standards, continually seeking opportunities for improvement in quality management.
- Uses lean tools, statistical techniques and analytical methods to achieve effective problem solving, root cause discovery and corrective action (8D Problem Solving, 5-Why).
- Track quality performance metrics, prioritize top issues, and drive continuous improvement activities with cross-functional teams.
- Work on continuous improvement of quality processes and procedures.
- Assists with the development of quality objectives complimentary to organization objectives.
- Provides technical support to all manufacturing areas, locations, and customers as needed.
- Provide technical expertise and mentorship to junior-level engineers and technicians.
- Lead and participate in initiatives to support Business and Quality objectives.
- Performs other duties as assigned.
- Experienced in ISO-9001 quality management systems.
- Bachelor’s degree in Engineering, Quality Assurance, or a related field. A Master’s degree is a plus.
- Minimum of 5 years of experience in Quality Engineering, with a focus on quality management systems, hardware product development and operations.
- Strong knowledge and practical experience in ISO 9001 standards and quality management methodologies.
- Proficient in quality tools and techniques such as Root Cause Analysis (RCA), Failure Mode Effects Analysis (FMEA), Statistical Process Control (SPC), and others.
- Excellent communication and interpersonal skills, with the ability to influence and engage stakeholders at all levels.
- Detail-oriented with strong analytical and problem-solving abilities.
- Certification in Quality Management, such as ASQ Certified Quality Engineer (CQE) or similar, is highly desirable.
- Ability to work in a fast-paced team environment.
- Experienced in IATF 16949, ISO 26262.
- Experience with Linux operating systems.
- Minitab or other statistical software capabilities.
- Experience programming and scripting (C++, Python or equivalent).
- Experience with Jira, Jama, Arena, and general familiarity with PLM, ERP, and MRP systems.
- Ability to communicate effectively with internal stakeholders and 3rd parties.
- Ability to travel to company locations in the continental U.S.
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