A minimum of 5 years experience in a related position within a Quality Assurance Department is required.
• Clean Room experience is required.
• An understanding of blueprint interpretation and Geometric Dimensioning and Tolerancing is mandatory.
• Must be able to interpret blueprints in accordance with ANSI YI4.5.
• Must have strong knowledge of ISO 13485 and other quality systems.
• An active membership in the American Society for Quality (ASQ) and an ASQ CQE are a plus.
Supervise WHK-QA Inspectors as needed. Carry out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include training employees; planning, assigning and directing work. Appraising performance, rewarding and disciplining employees and addressing complaints. Prepare documentation for MRB meeting; run meeting; process NMR’s; follow-up on action items; and update NMR database. Run Corrective Action meeting; follow-up with corrective action assignees. Conduct ISO Awareness Training. Supervise WHK supplier evaluation and audits. Develop; implement and coordinate control plans and documentation for new and existing manufactured parts. Develop and maintain visual aids for defect recognition. Train appropriate personnel on the use of the visual aids for defect recognition system. Develop and maintain operation specific work instructions and inspection standards. Train appropriate personnel on the use of these work instructions and inspection standards. Conduct capability studies, analyze results and report results as needed to President/Managing Member and other key divisional managers as directed. Create and maintain control plans and charts as necessary. Identify critical characteristics to be inspected for each part run in WHK manufacturing. Conduct root cause analysis for discrepancies and issue corrective action when deemed necessary. Review blueprints and customer standards during the quoting process to ensure inspection criteria can be met without incurring additional costs. Work directly with Operations during quoting process to help determine potential problems during product development and processing. Provide technical assistance to Quality Control personnel and all departments. Update and evaluate returned product under RMA process; interface with customer service and/or customer as necessary. Perform receiving inspection. Communicate effectively with customer on quality related problems. Lead the initiative to drive down defect rates by determining with parts need attention. As a team leader, work directly with involved departments, the Quality Manager is to systematically identify and correct the root cause of all product defects. Perform other duties as required.