Carolina Precision Technologies
Quality Manager
Carolina Precision Technologies, Warminster, Pennsylvania, United States, 18974
Job Type
Full-time
Description
Job Summary:Manage and coordinate all aspects of the company's day-to-day quality compliance and improvement efforts to ensure quality results meet or exceed internal and external customers' needs and expectations. As the quality manager and ISO management representative this position plans, coordinates, implements and maintains the Carolina Precision Quality Management System. This position provides direct support to the Director of Quality/Regulatory in support of CPT strategic goals and objectives that ensure compliance with Quality System requirements in a machine shop/manufacturing environment.
Responsibilities include, but not limited to:
Review customer documentation (e.g., drawing and specifications) during quote and incoming purchase order receipt for quality related requirements and gaging required.Maintain the complaint system and handle customer returns within CPT. Receive and report all customer reported and internally reported nonconformances. As the leader of the MRB Team, evaluate all nonconforming products for validity and disposition.Perform root cause investigations and initiate corrective and preventive actions as required per documented procedures within the QMS. Perform effectiveness checks to ensure all actions taken are implemented and effective at eliminating the original root cause of the issue.Communicate with customers/suppliers as needed regarding complaints, deviations, corrective and preventive actions, and audit results.Develop/Suggest changes to current QMS procedures/work instructions to continuously improve and streamline all processes within CPT.Monitor job performance and inspection department throughput to ensure product is inspected in a timely and efficient manner based on importance/delivery schedule.Coordinate on-the-job training for newly hired inspection staff as well as perform on-going training for product specific requirements.As needed, perform inspections to ensure conformance to customer requirements provided through blueprints and control documents prior to product release.Communicate all quality issues to fellow management team members in a timely manner, along with recommendations for any corrective or preventive actions that may be necessary.Manage the calibration program and ensure all inspection tools are calibrated in accordance with applicable requirements. Schedule all calibration activities to ensure no tools are used that are past or out of calibration. Monitor and track all tools within the calibration system.Coordinate and report KPI and quality objectives in monthly review meetings.Minimum Requirements:
Must be 18 years oldKnowledge of ISO 13485, and FDA 21CFR Part 820 requirementsAbility to perform root cause analysis using various tools (5 why, fishbone, 8D etc.)Experience with 3-dimensional inspection and measurementsKnowledge and understanding of engineering drawing interpretation with GD&T specified features.Preferred Requirements:
QA experience in medical devicesHigh School diploma or GED preferredAbility to utilize all inspection tools including calipers, micrometers, comparators, etc.Internal auditing experienceFamiliarity of AQL inspection methodsPossess organizational ability to set priorities, organize workload, and meet deadlinesPC skills, including Microsoft Office (Word, Excel, Access)Excellent record-keeping documentation and organizational skillsAbility to use ERP systems (Preferably VISUAL)Able to bend, stoop, twist, reach, lift 40 pounds and stand on feet for an extended period
Disclaimer:
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
Full-time
Description
Job Summary:Manage and coordinate all aspects of the company's day-to-day quality compliance and improvement efforts to ensure quality results meet or exceed internal and external customers' needs and expectations. As the quality manager and ISO management representative this position plans, coordinates, implements and maintains the Carolina Precision Quality Management System. This position provides direct support to the Director of Quality/Regulatory in support of CPT strategic goals and objectives that ensure compliance with Quality System requirements in a machine shop/manufacturing environment.
Responsibilities include, but not limited to:
Review customer documentation (e.g., drawing and specifications) during quote and incoming purchase order receipt for quality related requirements and gaging required.Maintain the complaint system and handle customer returns within CPT. Receive and report all customer reported and internally reported nonconformances. As the leader of the MRB Team, evaluate all nonconforming products for validity and disposition.Perform root cause investigations and initiate corrective and preventive actions as required per documented procedures within the QMS. Perform effectiveness checks to ensure all actions taken are implemented and effective at eliminating the original root cause of the issue.Communicate with customers/suppliers as needed regarding complaints, deviations, corrective and preventive actions, and audit results.Develop/Suggest changes to current QMS procedures/work instructions to continuously improve and streamline all processes within CPT.Monitor job performance and inspection department throughput to ensure product is inspected in a timely and efficient manner based on importance/delivery schedule.Coordinate on-the-job training for newly hired inspection staff as well as perform on-going training for product specific requirements.As needed, perform inspections to ensure conformance to customer requirements provided through blueprints and control documents prior to product release.Communicate all quality issues to fellow management team members in a timely manner, along with recommendations for any corrective or preventive actions that may be necessary.Manage the calibration program and ensure all inspection tools are calibrated in accordance with applicable requirements. Schedule all calibration activities to ensure no tools are used that are past or out of calibration. Monitor and track all tools within the calibration system.Coordinate and report KPI and quality objectives in monthly review meetings.Minimum Requirements:
Must be 18 years oldKnowledge of ISO 13485, and FDA 21CFR Part 820 requirementsAbility to perform root cause analysis using various tools (5 why, fishbone, 8D etc.)Experience with 3-dimensional inspection and measurementsKnowledge and understanding of engineering drawing interpretation with GD&T specified features.Preferred Requirements:
QA experience in medical devicesHigh School diploma or GED preferredAbility to utilize all inspection tools including calipers, micrometers, comparators, etc.Internal auditing experienceFamiliarity of AQL inspection methodsPossess organizational ability to set priorities, organize workload, and meet deadlinesPC skills, including Microsoft Office (Word, Excel, Access)Excellent record-keeping documentation and organizational skillsAbility to use ERP systems (Preferably VISUAL)Able to bend, stoop, twist, reach, lift 40 pounds and stand on feet for an extended period
Disclaimer:
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.