Quality Engineer I

Tecomet; Warsaw (IN); On-site; USD 60,000 - 80,000; Full time

Job summary

Tecomet in Warsaw, IN seeks a Quality Engineer I to ensure compliance with FDA/ISO regulations and support continuous improvement. You will work with manufacturing to resolve quality, cost, and schedule issues and prepare quality deliverables.

Responsibilities include FMEA, control plans, PPAP, process validations, CAPA, MRB, and quality metrics reporting. Experience with 8D, GD&T, metrology, and MS Office/Minitab is valued.

Qualifications

• Bachelor's degree in Engineering or related field; or 4+ years in medical device industry with certification.
• ASQ CQE or CMQ/QE preferred.

Responsibilities

• Maintain quality system and ensure FDA/ISO compliance.
• Facilitate operator-owned quality program.
• Support MRB and RMA processes.
• Collaborate with manufacturing/operations to solve quality, cost and schedule issues.
• Prepare FMEA, control plans, quality plans, and PPAP.
• Coordinate process validations and reduce dependence on inspection.
• Generate quality metrics reports (cost of quality and data-driven decisions).
• Investigate customer complaints including CAPA, deviations, and responses.
• Participate in audits and inspections.
• Apply Six Sigma tools and problem-solving approaches.

Skills

Quality systems

FDA/ISO regulations

GD&T

Metrology

8D problem solving

Minitab

Microsoft Office

Education

Bachelor's Degree in Engineering

ASQ CQE or CMQ/QE

Tools

Minitab

Microsoft Office

Job description

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.

• 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.
• Quality Systems.
• Regulations – FDA, GMP and ISO.
• GD&T.
• Metrology.
• Problem solving and 8D.
• Microsoft office (Word, Excel, Outlook, PowerPoint).
• Minitab.

Other Requirements

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.

Tecomet is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, age, genetic information, national origin, or protected veteran status and will not be discriminated against on the basis of disability.