Quality Manager

• Follows all ISO 9001/ ISO 13485 Procedures and Work Instructions in the performance of these duties. Assigned as the Management Representative for ISO 9001/ ISO 13485 implementation and maintenance.
• Coordinates Management Review Meetings and the ISO 9001/ ISO 13485 Internal Audit Team.
Manage, coordinate, and control all areas relating to Quality Control
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  • gage control - gage calibration, as well as, gage R & R
  • coordinate measuring functions
  • SPC - process evaluation
  • receiving, in-process, and final inspection
  • control plan development
• Responsible for all dimensional, metallurgical, and destructive testing on products
• Oversee the quality performance and development of our raw material suppliers and secondary sources performance monitoring quality audits.
• Plans, promotes, and organizes training activities related to product quality and reliability.
• Investigates customer complaints regarding quality and drives corrective actions to closure.
• Assists in product design, review, and evaluation through the Contract Review Team.
• Participates in Advanced Product Quality Planning.
• Leads the submittal of FAI/ PPAP
• Assists in the development of IQ/OQ/PQ protocol
• Promote a continuous improvement culture by identifying areas and processes to be considered for continual improvement, participate in continuous improvement initiative projects.
• Responsible for ensuring that proper equipment and well-trained people are available to perform the above tasks. Has the authority to discontinue production to correct a quality problem.
• Responsible for all long-range planning for the department.
• Ensure all safety practices are followed by all APG employees.

• UKG navigation- PTO approval, salary employee evaluations
• Minitab
• Knowledge of Relevant International Standards (ISO 9001, ISO 13485, etc.)
• Problem Solving and Root Cause with corrective action facilitation
• Knowledge and/or Training in AIAG Core Tools (APQP, FMEA, PPAP, MSA, SPC)
• Has a thorough understanding of IQ/OQ/PQ
• Understanding of blue print reading and GD&T
• Experience with Plex ERP System
• Microsoft Office Applications – Word, Excel, Power Point
• Root Cause Analysis Techniques – Ability to properly use Basic 5 Why, 5x3 Why, Fishbone Analysis and A3 Analysis
• Strong Analytical and Technical Skills
• Strong Interpersonal, Organizational, and Communication (verbal and written) Skills
• The ability to organize and manage multiple priorities

Plans, coordinates, and directs quality control program designed to ensure continuous production of parts consistent with established standards by performing the following duties personally or through subordinate supervisors.