Quality Control Engineer

Precision Medical Technologies, Incorporated; Warsaw (IN); On-site; USD 65,000 - 90,000; Full time

Job summary

Precision Medical Technologies, Incorporated in Indiana is seeking a Quality Engineer to maintain and improve quality standards across materials, processes, and products. You will oversee quality control, audit readiness, and drive continuous improvement initiatives to boost product quality and manufacturing efficiency.

The role collaborates with Engineering, Operations and Supply Chain, uses SPC and GD&T to solve problems, and mentors staff on QA processes and documentation.

Qualifications

• 5 years in related field experience.
• Minimum of two years of college experience or 7 years related field experience.
• Familiar with statistical techniques (SPC, sampling theory, probability, reliability).

Responsibilities

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

Skills

Statistical techniques

Blueprint reading

GD&T interpretation

Metrology basics

Verbal and written communication

Problem-solving

Education

Bachelor's degree in Engineering or related field

Two years college or 7 years related experience

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.

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.

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 (not Necessary But 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