Quality Engineer I

Tecomet, Inc; Warsaw (IN); On-site; USD 55,000 - 80,000; Full time

Job summary

Tecomet, Inc is seeking a Quality Engineer I to ensure compliance with internal and external quality requirements in Warsaw, Indiana. The role involves maintaining quality systems, facilitating quality programs, and applying regulatory standards.

The ideal candidate should possess a Bachelor’s degree in Engineering and have experience in the medical device industry. Responsibilities also include investigating customer complaints, conducting audits, and leading special projects to enhance quality.

The position may require up to 10% travel.

Qualifications

• Certification (ASQ CQE or CMQ/QE) is preferred.
• Experience in quality within medical device manufacturing industry is a plus.

Responsibilities

• Maintain quality system, environmental, and FDA requirements.
• Facilitate operator owned quality program.
• Investigate customer complaints and execute CAPA.
• Apply Good Manufacturing Practices and Good Documentation Practices.

Skills

Manufacturing operations – forging and/or machining

Quality systems

Regulations – FDA, GMP and ISO

Math skills (algebra, trigonometry)

Microsoft Office (Word, Excel, Outlook, PowerPoint)

Minitab

Education

Bachelor’s Degree in Engineering or a related field

Minimum of 4 years’ experience within the Medical Device Industry

Job description

Position Summary

The Quality Engineer I will interact with team members to ensure compliance and internal and external customer requirements are met, with focus on quality engineering. This will be accomplished within Tecomet’s principles of continuous improvement, customer driven innovation and a win first culture, while meeting company financial and other performance metrics.

Responsibilities

• Maintain applicable quality system, environmental, and FDA requirements/certifications.
• Facilitate operator owned quality program.
• Support the MRB and RMA processes.
• Work with team members and support manufacturing/operations to solve quality, cost and schedule issues.
• Prepare FMEAs, controls plans, quality plans, and PPAP.
• Coordinate process validations and reduce dependence on inspection.
• Generate applicable quality metric reports; cost of quality, management by facts.
• Investigate customer complaints including associated actions such as CAPA, deviations, and complaint responses.
• Perform special projects as assigned by quality management.
• Demonstrate a working knowledge of standard manufacturing operations, FDA, and ISO regulations.
• Apply Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) requirements.
• Use standard problem‑solving techniques.
• Apply statistical and Six Sigma concepts and techniques.
• Work with internal and external customers.
• Participate in audits and inspections.

Qualification Requirements

• Bachelor’s Degree in Engineering or a related field, or a minimum of 4 years’ experience within the Medical Device Industry, and Certification (ASQ CQE or CMQ/QE).

Preferred Experience and Education

• ASQ CQE or CMQ/QE certification.
• 2 years’ experience in quality within medical device manufacturing industry.
• ISO 13485, FDA 820, and customer interaction experience.

Knowledge, Skills, and Abilities

• Manufacturing operations – forging and/or machining.
• Measuring devices.
• Quality systems.
• Regulations – FDA, GMP and ISO.
• Blueprint reading.
• GD&T.
• Metrology.
• Problem solving and 8D.
• Math skills (algebra, trigonometry).
• Microsoft Office (Word, Excel, Outlook, PowerPoint).
• Minitab.

Work Environment

The work environment is representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Physical Requirements

The employee may frequently be required to walk, use hand to finger, handle, or feel; reach with hands and arms and talk or hear. The employee may be required to sit, climb or balance and stoop, kneel, crouch, or crawl. The employee may occasionally lift and/or move up to 50 pounds. Specific vision abilities required by the job may include close vision, distance vision, peripheral vision and ability to adjust focus.

Travel Requirements

Up to 10 %.

Americans with Disabilities Act (ADA)

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Equal Opportunity Employer

Minorities/Women/Protected Veterans/Disabled.