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Quality Engineer
4 weeks ago
Job Title: Quality Engineer
Locations: Alameda, California, USA
Key Responsibilities:
- Quality Systems Management: Develop, implement, and maintain quality systems in compliance with ISO 13485 and FDA 21 CFR Part 820 regulations.
- CAPA (Corrective and Preventive Action): Lead root cause investigations, develop corrective action plans, and monitor effectiveness.
- Nonconformance Management: Identify, document, and resolve product non conformance issues. Lead cross-functional teams to determine appropriate corrective actions.
- Risk Management: Support risk analysis activities, including FMEA (Failure Modes and Effects Analysis) and other risk management tools.
- Process Validation: Assist in the development and execution of IQ/OQ/PQ (Installation Qualification/Operational Qualification/Performance Qualification) validations to ensure manufacturing processes meet quality standards.
- Supplier Quality: Collaborate with suppliers to ensure quality standards are met for incoming materials and components. Conduct supplier audits as needed.
- Internal Audits: Conduct internal audits of the quality system to ensure compliance with applicable regulations and standards.
- Design Control: Provide quality engineering support for design control activities including design verification, validation, and design transfer.
- Documentation: Ensure all quality records, procedures, and work instructions are complete, accurate, and in compliance with quality system requirements.
- Continuous Improvement: Identify and implement process improvements to enhance product quality, reduce costs, and increase efficiency.
Qualifications:
- Education: Bachelor’s degree in Engineering, Biomedical, Mechanical, Electrical Engineering, or a related field.
- Experience: Minimum 3 years of experience in a quality engineering role within the medical device industry.
- Regulatory Knowledge: Familiarity with FDA 21 CFR Part 820, ISO 13485, and other relevant medical device regulations and standards.
- Technical Skills: Experience with CAPA, root cause analysis, nonconformance management, and risk management processes.
- Software Skills: Proficient in Microsoft Office (Word, Excel, PowerPoint) and experience with quality management systems (QMS) software.
- Certifications: CQE (Certified Quality Engineer) or other relevant quality certifications (preferred).
- Problem-Solving Skills: Strong analytical and problem-solving abilities with attention to detail.
- Communication: Excellent written and verbal communication skills to work effectively in a cross-functional team environment.
