Quality Engineer I

Orchid Orthopedic Solutions; Claypool (IN); Sur place; USD 60 000 - 80 000; Plein temps

Résumé du poste

Orchid Orthopedic Solutions LLC in Indiana seeks a Quality Engineer I to ensure compliance with FDA, ISO, GMP and GDP standards while supporting continuous improvement and customer-driven quality.

You will work with manufacturing to solve quality, cost and schedule issues; prepare FMEA, control plans, PPAP; coordinate validations; and investigate complaints with CAPA and deviations.

Bachelor’s degree in engineering or 4+ years in medical device quality; ASQ CQE/CMQ/QE preferred.

Qualifications

• Bachelor’s degree in engineering or related field, or 4+ years in medical device quality
• ASQ CQE or CMQ/QE certification preferred
• 2+ years of quality experience in medical device manufacturing preferred
• ISO 13485, FDA 820 familiarity and customer interaction preferred

Responsabilités

• Maintain applicable quality system, environmental, and FDA requirements/certifications.
• Facilitate operator owned quality program.
• Support 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, 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.

Connaissances

Measuring devices

Quality Systems

Regulations

Blueprint reading

GD&T

Metrology

8D problem solving

Math skills

Microsoft Office

Minitab

Formation

Bachelor's Degree in Engineering or related field

ASQ CQE or CMQ/QE

Description du poste

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.

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.