Job Description
The Quality Engineer will develop and maintain the Quality Management System for hardware products, ensuring ISO 9001 compliance, leading quality improvement initiatives, and collaborating across teams to enhance product quality and safety in a fast-paced, innovative environment.
Key Responsibilities
- Develop, implement, and maintain the Quality Management System (QMS) in accordance with ISO 9001 standards for hardware product design and development.
- Collaborate with cross-functional teams to integrate quality standards throughout the product lifecycle.
- Conduct internal audits, risk assessments, and management reviews to ensure ISO 9001 compliance and drive continuous 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 tools like root cause analysis and statistical techniques.
- Facilitate quality improvement initiatives employing methodologies such as Six Sigma and Lean principles.
- Serve as the primary contact for ISO 9001 audits and inquiries from 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 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.
- Ability to develop, implement, and maintain the Quality Management System (QMS) in alignment with ISO 9001 standards for hardware product design and development processes.
- Ability to conduct internal audits, risk assessments, and management reviews to ensure compliance with ISO 9001 and continuous improvement of the QMS.
- Ability to analyze data and metrics related to product quality, troubleshoot issues, and implement corrective actions as necessary.
- Experience leading and coordinating quality-related training programs for staff to increase awareness and ensure adherence to quality processes and standards.
- Ability to facilitate 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.
- Proficiency in using 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 with providing technical support to manufacturing areas, locations, and customers as needed.
- Ability to provide technical expertise and mentorship to junior engineers and technicians.
- Willingness to perform other duties as assigned.
Benefits & Perks
Base salary range of $181,000 to $290,000 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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