Quality Engineer I

tecometunitedstates; Warsaw (IN); On-site; USD 65,000 - 90,000; Full time

Job summary

Tecomet is seeking a Quality Engineer I to ensure compliance with quality systems, FDA and ISO requirements, and customer specifications. You will support MRB/RMA, CAPA, FMEA, control plans and PPAPs while collaborating with manufacturing and operations to solve complex quality, cost, and schedule challenges.

The role requires a Bachelor’s degree in engineering or equivalent experience in medical devices, with ASQ CQE/CMQ/QE preferred.

Qualifications

• Bachelor’s Degree in Engineer or related field, or minimum of 4 years in medical device industry with certification (ASQ CQE or CMQ/QE).
• ASQ CQE or CMQ/QE preferred.
• 2 years’ experience in quality within medical device manufacturing preferred.
• ISO 13485, FDA 820 and customer interaction experience preferred.

Responsibilities

• Maintain applicable quality systems, environmental, and FDA requirements/certifications.
• Facilitate operator owned quality program.
• Support MRB and RMA processes.
• Solve quality, cost and schedule issues with manufacturing/operations.
• Prepare FMEAs, control plans, quality plans, and PPAPs.
• Coordinate process validations and reduce dependence on inspection.
• Generate quality metrics and CAPA, deviations, and complaint responses.
• Participate in audits and inspections.

Skills

Quality systems

GMP

GD&T

Minitab

8D problem solving

Metrology

Blueprint reading

Statistical methods

MS Excel

Education

Bachelor's degree in Engineering

ASQ CQE or CMQ/QE (preferred)

Tools

Minitab

MS Office

Job description

Quality Engineer I

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.

Principle Responsibilities

• Maintaining applicable quality system, environmental, and FDA requirements/certifications.
• Facilitate operator owned quality program.
• Supporting the MRB and RMA processes.
• Work with team members and support manufacturing/operations to solve quality, cost and schedule issues.
• Prepare FMEA’s, controls plans, quality plans, PPAP.
• Coordinate process validations and reduce dependence on inspection.
• Generating applicable quality metric reports; cost of quality, management by facts.
• Investigate customer complaints including associated actions including CAPA, deviations, and complaint responses.
• Special projects as assigned by quality management.
• Must demonstrate a working knowledge of standard manufacturing operations, FDA and ISO regulations.
• Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) requirements.
• Standard problem-solving techniques.
• Applies statistical and Six Sigma concepts and techniques.
• Works with Internal and External Customers.
• Participates in audits and inspections.

Qualification Requirements

Credentials/Experience:

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

Experience/Educational/Training Preferred

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

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) skills.
• Microsoft office (Word, Excel, Outlook, PowerPoint).
• Minitab.

Work Environment

The work environment characteristics described here are 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 could frequently be required to walk; use hand to finger, handle, or feel; reach with hands and arms and talk or hear. The employee could be required to sit; climb or balance and stoop, kneel, crouch, or crawl. The employee could occasionally lift and or move up to 50 pounds. Specific vision abilities required by the job could 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.

The statements herein are intended to describe the general nature and level of work being performed by employees and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of the Company.