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Engineer - Quality

Job Code - EC0801

Quality Manager: cable assembles ( Near St. Paul MN)
The Quality Manager is responsible for administration, maintenance and auditing of the company Quality Management System. This includes industry regulations and continuous improvement in support of defined key process metrics. Management of CAPA (Corrective/Preventive action), NCM (Non-Conforming Materials, Internal Audits and Management Review process. The position will train and coach on root cause analysis and problem solving with resources to support quality and cost initiatives. The position will coordinate inspection and proper integration of quality tools to improve existing processes, support manufacturing product conformance and new product development activities.

Essential Functions:
1.) Ensures continual quality management system process compliance and improvement including ISO 9001, ISO13485, AS9100, ISO14971, customer, regulatory, and statutory requirements.
2.) As the selected management representative, ensures that processes needed for the quality management system are documented, reports to top management on the effectiveness of the quality management system and any need for improvement, and ensures the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization.
3.) Provides support to maintain compliance to UL and CSA requirements. Maintain Supervised Manufacturers Testing Certification (SMTC). Coordinate compliance to new requirements (national or international) as identified.
4.) Drives corrective action and root cause closures of failure events for such audits that require corrective actions, findings from internal audits and customer audits. Be the point person for all internal and customer audits.
5.) Manage department personnel and coordinate internal resources to support department activity (calibration, return material authorization, first article, gauge R&Rís, incoming inspection, in-process inspection, VQC, electrical inspection and statistical process control).
This position will be responsible for direct reports that include quality department personnel. Leadership and management requirements include the following: talent retention and acquisition, performance management, performance appraisals, TEAM Member development and project management. Collaborate with various departments, such as Assembly, Production, Customer Service, Scheduling, Supply Chain, and Quality to support quality improvements and on-time shipment.
Required Education and Experience:
6.) Bachelorís degree in quality, manufacturing, engineering, business, or equivalent experience
7.) 10+ years in manufacturing
8.) 5+ years of leadership
9.) 5+ years ISO 13485 (based) quality systems
10.) ISO 9001, ISO13485 and/or AS9100 lead auditor
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