Quality Control Engineer

Precision Medical Technologies, Incorporated; North Manchester (IN); On-site; USD 75,000 - 105,000; Full time

Job summary

Precision Medical Technologies, Incorporated is seeking a Quality Engineer to safeguard product quality and drive continuous improvement across manufacturing and supply chain. You will develop QA protocols, perform supplier and internal audits, and lead corrective actions.

You will analyze quality metrics, interpret GD&T, apply metrology principles, and mentor staff on standards. This role requires strong communication, problem solving, and proficiency with MS Office tools, with ISO 13485

Qualifications

• 5 years in 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 interpreting GD&T.
• Fundamental understanding of metrology and measurement tools.
• Excellent verbal and written communication skills.

Responsibilities

• Develop, implement, and maintain QA protocols to ensure compliance with standards.
• Conduct inspections and tests on materials, in-process components, and finished products.
• Collaborate with Engineering, Operations, and Supply Chain to resolve quality issues.
• Lead root cause analysis and corrective actions for non-conformances.
• Maintain quality plans, inspection records, and audit reports.
• Perform internal and supplier audits to assess compliance and identify improvements.
• Train and mentor production staff on quality control processes and standards.
• Monitor quality metrics and report performance to management.
• Drive continuous improvement to reduce defects and optimize processes.
• Stay current with industry trends, regulatory changes, and quality practices.

Skills

Statistical methods

GD&T reading

Metrology basics

Root cause analysis

Quality process knowledge

Problem solving

Education

2+ years college or 7+ years field experience

4-year college degree

Tools

MS Word

MS Excel

MS Project

Job description

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.

DUTIES AND RESPONSIBILITIES (essential Functions of Position)

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.

Qualifications

Essential Education, Skills, Experience and Qualifications

• 5 years in 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 interpreting 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

Nonessential Skills, Experience and Qualifications (Preferred)

• 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