Job Description
The Quality Engineer will develop, maintain, and improve the company's Quality Management System (QMS) in compliance with ISO 9001 standards, ensuring hardware product quality throughout the development and operational processes, while collaborating with cross-functional teams and leading continuous improvement initiatives.
Key Responsibilities
- Develop, implement, and maintain the Quality Management System (QMS) in compliance with ISO 9001 standards for hardware product design and development.
- Collaborate with cross-functional teams to ensure quality standards are integrated throughout the product lifecycle.
- Conduct internal audits, risk assessments, and management reviews to ensure ISO 9001 compliance and continuous QMS improvement.
- Lead quality-related training programs to increase staff awareness and adherence to quality standards.
- Analyze quality data, troubleshoot issues, and implement corrective actions using methodologies like Six Sigma and Lean.
- Facilitate quality improvement projects to enhance product quality and operational efficiency.
- Serve as the primary contact for ISO 9001 inquiries and audits by external bodies and regulatory agencies.
- Maintain accurate documentation and records related to quality activities, audits, and compliance.
Requirements
- Experience in ISO-9001 quality management systems.
- Bachelor's degree in Engineering, Quality Assurance, or a related field.
- 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 other relevant quality tools.
- 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.
- Ability to develop, implement, and maintain the Quality Management System (QMS) in alignment with ISO 9001 standards for hardware product design and development processes.
- Experience conducting internal audits, risk assessments, and management reviews to ensure compliance with ISO 9001 and continuous improvement of the QMS.
- Experience leading and coordinating quality-related training programs for staff to increase awareness and ensure adherence to quality processes and standards.
- Ability to analyze data and metrics related to product quality, troubleshoot issues, and implement corrective actions as necessary.
- Experience facilitating quality improvement projects and initiatives employing methodologies such as Six Sigma and Lean principles.
- Ability to act as the primary point of contact for ISO 9001-related inquiries and audits by external bodies and regulatory agencies.
- Ability to maintain accurate documentation and records related to quality activities, audits, and compliance assessments.
- Ability to stay current with industry trends, best practices, and updates related to ISO standards, continually seeking opportunities for improvement in quality management.
- Ability to use lean tools, statistical techniques, and analytical methods to achieve effective problem solving, root cause discovery, and corrective actions (e.g., 8D Problem Solving, 5-Why).
- Experience tracking quality performance metrics, prioritizing top issues, and driving continuous improvement activities with cross-functional teams.
- Experience working in a fast-paced team environment.
- Desirable: Experience in IATF 16949 and ISO 26262 standards.
- Desirable: Experience with Linux operating systems.
- Desirable: Experience with Minitab or other statistical software.
- Desirable: Programming and scripting skills in C, Python, or equivalent.
- Desirable: Experience with Jira, Jama, Arena, and familiarity with PLM, ERP, and MRP systems.
- Ability to travel to company locations in the continental U.S.
Benefits & Perks
Base salary range of $150,000-$240,000 per year
Eligibility for an annual bonus
Equity compensation
Hybrid work environment with in-office presence at least 3 days per week
Ready to Apply?
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