What are the responsibilities and job description for the Quality Assurance Engineer position at Tecomet, Inc?
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 – 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.
Other Requirements
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 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 – 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.
Other Requirements
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.