Quality an Regulatory Control Specialist

Jimmy Jazz; Franklin (IN); On-site; USD 52,000 - 78,000; Full time

Job summary

Jimmy Jazz is seeking a Quality Control Specialist in Franklin, IN to create and organize inspection plans, program the CMMs, and maintain calibration records for gaging tools and machined components.

You will interpret drawings and GD&T, conduct 1st Article inspections, support CAPA, and train junior inspectors to uphold ISO 13485 and related standards.

Qualifications

• Experience in quality control or quality assurance within a precision CNC machining environment.
• Experience with internal audits, CAPA, nonconformance management, and root-cause analysis.
• Proficient in reading and interpreting engineering drawings, technical specs, and work instructions.
• ASQ Certified preferred.

Responsibilities

• Create and organize inspection plans.
• Programming of the CMM according to the inspection plan.
• Create accurate and complete records for inspections and calibrations performed.
• Calibration workflows and maintaining calibration status.
• Independent decision to accept/reject parts based on specification.
• Notify appropriate team members of quality issues such as failed 1st Articles or calibrations.
• Provide guidance to less senior inspectors on inspection methods.
• Train new inspectors.
• Promote adherence to work instructions and quality procedures.
• Collaborate with machine shop floor on 1st Articles.

Skills

Quality control

CMM programming

Calibrations

Inspection planning

GD&T interpretation

Education

Associate degree

Bachelor's degree

Tools

MS Excel

ERP software

Quality software tools

Job description

• Location 700 International Dr,Franklin, IN, 46131-9733,United States


• Job Category Inspections, CMM Programming, Calibrations


• Industry Medical Device, Aerospace , Machining


• Employee Type Salary Exempt


• Required Degree 2 Year Degree


• Manage Others No

The Quality Control Specialist creates and organizes plans to ensure that parts or accurate, complete within the specific customers guidelines and quality standards. They will also inspect 1 st Article of machined components and purchased component inspections. They will be active in maintaining calibrations on gaging tools.

• Create and organize inspection plans.


• Programming of the CMM according to the inspection plan


• Create accurate and complete records for inspections and calibrations performed.


• Calibration


• Independent decision to accept/reject parts based on specification not being met


• Independent decision to prioritize work unless changed by supervisor


• Notify appropriate team members of any quality issues such as failed 1 st Articles, failed calibrations, and any issues with parts or measurement tools that could impact the quality and performance of product.


• Provide guidance to less senior inspectors on the best method of inspection according to the inspection plan.


• Train new inspectors


• Provide guidance to other inspectors on best method/practice for inspecting


• Actively working with the machine shop floor team on 1 st Articles


• Other duties as assigned

RESPONSIBILTIES

• Conduct internal audits of manufacturing processes and the Quality Management System.


• Support compliance with applicable requirements, including ISO 13485, AS9100, and ISO 9001.


• Document audit findings, issue corrective actions, track completion and effectiveness.


• Manage nonconforming material, including identification, segregation, investigation, and disposition.


• Lead or support CAPA and root-cause investigations (8D process) using tools such as 5 Whys, Fishbone (cause and effect/6M), and Is/Is not analysis.


• Analyze scrap, rework, yield, and cost-of-poor-quality data. Develop Pareto charts, trends, and reports to identify recurring defects and improvement opportunities.


• Partner with production, engineering, and programming personnel to reduce scrap and prevent repeat issues.


• Perform or support inspections using precision measuring equipment, including micrometers, optical systems, and other inspection tools.


• Interpret engineering drawings, GD&T, inspection plans, and customer specifications.


• Support first article inspections, inspection documentation, calibration activities, and customer or registrar audits.


• Promote consistent adherence to work instructions, quality procedures, and production controls.


• Other duties as assigned

REQUIREMENTS

• Experience in quality control or quality assurance within a precision CNC machining environment.


• Experience with internal audits, CAPA, nonconformance management, and root-cause analysis.


• Proficient in reading and interpreting engineering drawings, technical specs, and work instructions 5+ years inspection experience in a manufacturing environment


• Ability to analyze quality and scrap data using Microsoft Excel or similar tools.


• Authority to accept/reject parts and make work priorities unless changed by supervisor


• Familiarity with ISO 13485, AS9100, or ISO 9001 preferred.


• ASQ, Six Sigma, or internal auditor certification preferred.


• Strong attention to detail, communication skills, and problem-solving ability.


• US Person required – ITAR compliant


• Must pass a background with no felony convictions -FFL compliant


• Read and interpret gages


• Ability to learn and use software in order to perform job functions utilizing business systems and quality software tools.

EDUCATION & EXPERIENCE

• Associate or Bachelor’s preferred


• 5+years inspection experience in a regulated environment, medical device ISO 13485 and aerospace highly preferred


• ASQ Certified preferred


• ERP software


• MS Office

Physical Demands

• 40% of walking the production floor


• 10 lb. lifting

Fosters a culture which aligns with the overall goals and values of the GMI Pillars.