Quality Control Engineer

Job Location:

North Manchester, IN 46962

Position Summary: The Quality Engineer will play a critical role in maintaining and improving quality standards within Precision Medical Technologies. This position will involve overseeing quality control processes, ensuring compliance with industry regulations, and driving continuous improvement initiatives to enhance product quality and operational efficiency.

Nothing in this job description limits management's ability to assign or reassign duties and responsibilities at any time.

• Develop, implement, and maintain quality assurance protocols and procedures to ensure compliance with industry standards and regulations.
• Conduct thorough inspections and tests on raw materials, in-process components, and finished products to verify conformance to specifications.
• Collaborate with cross‑functional teams, including Engineering, Operations, and Supply Chain, to identify and resolve quality issues.
• Lead root cause analysis and corrective action processes to address non‑conformances and implement preventive measures.
• Develop and maintain detailed documentation, including quality plans, inspection records, and audit reports.
• Perform internal and supplier audits to assess compliance with quality standards and identify areas for improvement.
• Train and mentor production staff on quality control processes, standards, and best practices.
• Monitor and analyze quality performance metrics and provide regular reports to management.
• Drive continuous improvement initiatives to enhance product quality, reduce defects, and optimize manufacturing processes.
• Stay current with industry trends, regulatory changes, and advancements in quality engineering practices.

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

• 4‑year college degree.
• Minimum of 3 years of quality assurance management experience in a manufacturing environment, preferably Medical.
• Effective problem‑solving skills such as Lean Six Sigma, etc.
• Medical device or other health‑related field experience.
• ASQ Certified Quality Manager (CQM).
• CQM Certified Quality Manager.
• Ability to perform FMEA / PFMEA.