Quality Assurance Specialist
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We are seeking a Quality Assurance Specialist to join our team. This role will be responsible for ensuring products meet quality standards by developing procedures, analyzing data, managing audits, and resolving production issues.
Key Responsibilities:
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* Collaborate with engineering, suppliers, and production teams to improve processes and ensure regulatory compliance.
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* Support New Product Introductions with R&D and Production.
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* Develop and update manufacturing work instructions and procedures.
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* Liaise with suppliers for technical and quality issues.
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* Oversee sheet metal fabrication and electrical assembly.
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* Manage Bills of Material and drive cost-saving initiatives.
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* Coordinate preventive maintenance and external contractors.
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* Conduct safety audits, attend meetings, and support 5S.
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* Lead ISO and other regulatory audits.
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* Collect and analyze quality data for senior management.
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* Address quality issues via Corrective Action Reports.
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* Manage supplier returns, credits, and quality KPIs.
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* Host internal quality meetings and prepare reports.
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Requirements:
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* 2+ years' experience in a similar position.
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* Qualification in Mechanical or Electrical Engineering (non-FDA preferred).
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* Experience in sheet metal and electrical assembly highly desired.
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* Proficient in AutoCAD Inventor and Excel.
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