QA Engineer
2 weeks ago
Key Responsibilities
Quality Assurance & Compliance
- Select and apply appropriate problem-solving techniques to identify root causes and implement effective corrective and preventive actions (CAPA, NCEP, 8D, FMEA).
- Review and interpret technical drawings, validation data, and test reports to ensure compliance with specifications and performance standards.
- Ensure adherence to QSR, ISO 13485, ISO 9001, and IATF 16949 quality system requirements.
- Lead and support internal audits, supplier audits, and regulatory inspections as required.
- Maintain independent authority to make decisions related to product quality, including disposition of non-conforming products.
Nonconformance & Customer Quality Management
- Manage MRB (Material Review Board) activities and ensure timely disposition of non-conformances.
- Lead customer complaint investigations, prepare detailed analysis reports (e.g., GCS2), and ensure effective containment and corrective actions.
- Handle RMA coordination, sample submission, and continuous communication with customers to ensure satisfaction.
- Prevent outflow of defective parts and monitor corrective action effectiveness.
Process & Continuous Improvement
- Lead and facilitate process line audits and quality improvement projects.
- Collaborate with Operations, Engineering, and Suppliers to drive NPI (New Product Introduction) quality requirements and FAI (First Article Inspection) qualification.
- Support product transfer, process validation, and vendor qualification activities.
- Promote a culture of continuous improvement and innovation through data-driven analysis and best practices.
Leadership & Collaboration
- Provide technical guidance and mentorship to Quality Engineers, Associates, and Technicians.
- Work closely with suppliers and cross-functional teams to resolve quality issues and enhance product reliability.
- Support EHS initiatives by identifying and mitigating environmental and safety impacts within the quality domain.
- Serve as a trainer or subject matter expert for quality systems and complaint handling processes.
Requirements
- Bachelor's Degree in Engineering or related field.
- Minimum 9 years of experience in Operations Quality, preferably in medical device or electronic component manufacturing industries.
- Strong background in problem-solving tools, data analysis, and risk assessment methodologies.
- Hands-on experience with CAPA, NPI, FAI, MRB, and process validation.
- Familiar with ISO 13485, ISO 9001, and IATF 16949 standards.
- Excellent communication and cross-functional leadership skills.
- Experience in product transfer and supplier quality management will be an added advantage.
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