Senior Quality Engineer, Medical Devices

Paycom - ATS; Warsaw (IN); On-site; USD 70,000 - 110,000; Full time

Job summary

Precision Medical Technologies is seeking a Quality Engineer to maintain and improve quality standards across materials, in-process components, and finished products. You will drive QA protocols, audits, CAPA, and cross-functional collaboration to resolve quality issues.

The role emphasizes root cause analysis, documentation, and continuous improvement, with attention to regulatory compliance and operational efficiency within a manufacturing environment.

Qualifications

• 5 years in related field experience.
• Minimum of two years of college experience or 7 years related field experience.
• Capable of using statistical techniques: sampling theory, probability, reliability, capability, SPC.
• Ability to read blueprints and interpreting GD&T.
• Fundamental understanding of metrology and common dimensional measuring instruments.
• Excellent verbal and written communication skills.
• Computer knowledge: MS Word; MS Excel; MS Project.
• Logical cognitive skills and ability to apply scientific methods.
• Ability to identify variables affecting quality.
• Perform all duties of Corrective and Preventive Actions.

Responsibilities

• Develop, implement, and maintain quality assurance protocols and procedures.
• Conduct inspections and tests on raw materials, in-process components, and finished products.
• Collaborate with Engineering, Operations, and Supply Chain to resolve quality issues.
• Lead root cause analysis and corrective action processes (CAPA).
• Develop and maintain quality plans, inspection records, and audit reports.
• Perform internal and supplier audits to assess compliance.
• Train and mentor production staff on QC processes and best practices.
• Monitor quality performance metrics and report to management.
• Drive continuous improvement to enhance product quality and manufacturing efficiency.
• Stay current with industry trends and regulatory changes.

Skills

Statistical methods

GD&T reading

Metrology basics

Quality documentation

Internal audits

Communication skills

Root cause analysis

CAPA processes

Quality control

Problem-solving

Education

4-year college degree

ASQ Certified Quality Manager

Bachelor-level coursework in QA/Engineering

Tools

MS Word

MS Excel

MS Project

Job description

Precision Medical Technologies is seeking a Quality Engineer to maintain and improve quality standards across materials, in-process components, and finished products. You will drive QA protocols, audits, CAPA, and cross-functional collaboration to resolve quality issues.

The role emphasizes root cause analysis, documentation, and continuous improvement, with attention to regulatory compliance and operational efficiency within a manufacturing environment.