Quality Engineer
Job Summary
The Quality Engineer will be responsible for maintaining the quality management system and driving continuous quality improvements. This role involves close collaboration with the Assistant Quality Manager to oversee supplier management and ensure product quality standards are met. You will manage corrective actions, conduct audits, and ensure compliance with ISO standards across production and engineering departments.
Responsibilities
- Manage supplier on-boarding, audits, and performance monitoring.
- Oversee CAPA processes, non-conformance reports, and customer complaints.
- Maintain ISO 9001, 14001, and 13485 quality documentation.
- Lead Material Review Board (MRB) meetings and root cause analysis.
- Conduct internal/external audits and ensure regulatory compliance.
Required Skills
- 3-5 years manufacturing quality/audit experience
- ISO 9001/14001/13485 expertise
- PFMEA, Control Plans, and GR&R knowledge
- 8D and 5W problem-solving skills
- Supplier management experience
Job Details
### Key Responsibilities
- Participate in supplier on-boarding, selection, and approval processes, including auditing supplier facilities and establishing quality agreements.
- Evaluate and monitor supplier performance and identify opportunities for enhancements.
- Support new supplier/material qualification to ensure compliance with quality standards.
- Collaborate with procurement, warehouse, and manufacturing teams to address material defects and manage SCAR (Supplier Corrective Action Request) systems.
- Implement quality inspection standards for incoming and outgoing materials.
- Manage Corrective and Preventive Actions (CAPA), investigate non-conformances, and handle customer complaints.
- Lead Material Review Board (MRB) meetings to conduct root cause analysis and implement corrective actions.
- Maintain documentation for ISO 9001, 14001, and 13485 systems to ensure compliance.
- Plan and conduct internal and external audits to prepare for third-party certifications and customer reviews.
### Requirements & Expertise
- Diploma in Quality Management, Engineering, Manufacturing, or a related field.
- 3 to 5 years of relevant working experience in audits and ISO documentation within the manufacturing industry.
- Strong knowledge of Supplier Management processes.
- Proficiency in Quality Management Standards including ISO 9001, 14001, 13485, and ISO 22301.
- Experience with PFMEA, Control Plans, and Gage R&R.
- Familiarity with 8D and 5W problem-solving methodologies.
- Strong communication, presentation, and organizational skills.
- Ability to multitask, take initiative, and work independently with a positive attitude.