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Assurance Quality Manager
2 weeks ago
The role of Quality Assurance Specialist is crucial to ensuring products meet quality standards. The successful candidate will develop procedures, analyze data, manage audits, and resolve production issues.
Key Responsibilities:- Collaborate with R&D and Production teams on New Product Introductions
- Manage Engineering Change Notices and documentation
- Develop and update manufacturing work instructions and procedures
- Liaise with suppliers for technical and quality issues
- Oversee sheet metal fabrication and electrical assembly processes
- Manage Bills of Material and implement cost-saving initiatives
- Coordinate preventive maintenance and external contractor activities
- Conduct safety audits, attend meetings, and promote 5S practices
- Lead ISO and other regulatory audits
- Collect and analyze quality data for senior management
- Address quality issues via Corrective Action Reports
- Manage supplier returns, credits, and quality KPIs
- Host internal quality meetings and prepare reports
- 2+ years' experience in a similar position
- Qualification in Mechanical or Electrical Engineering (non-FDA preferred)
- Experience in sheet metal and electrical assembly highly desired
- Proficient in AutoCAD Inventor and Excel
