Quality Engineer
On-siteAustin, Texas, United States
Austin, Texas, United StatesOn-siteFull TimeLarge
Full TimeLarge
Job Summary
Conduct technical quality analysis and tests of the quality control program while preparing and analyzing customer claims for rejected or defective products. Prepare, implement, and maintain the Master Quality Plan, including involvement in validation processes (IQ, OQ, PQ) and continual improvement activities using 5S and lean methods. Perform internal audits, manage nonconformance systems and COPQ initiatives, and facilitate data collection and control charting to drive process validation. Support incoming inspection, manage RMA scrap disposal, and assist in developing training to build quality awareness across the team.
Required Qualifications
- A bachelor's degree in engineering or other technical discipline degree
- A minimum of 2 years of experience in quality engineering or related field
- Application and implementation of (GMP/QSR/ISO/MDD and Canadian Medical Device) regulations
- Focus on process validations
- Product development supports
- Required knowledge of FDA/GMP, CMDR, MDD and ISO 13485 quality standards
- Statistical aptitude
- Understanding of concepts of geometric dimensioning and tolerance
- Knowledge of problem solving techniques
- Personal computer skills
- Excellent verbal and written communication skills
- Full-time work authorization in the United States, both now and in the future, without requiring sponsorship
Desired Qualifications
- ASQ certification with active local membership
- Lean Six Sigma Green Belt or higher
- Experience with Quality related tools (D and P FMEA, QFD, SPC, Risk Analysis, DOE, and TQM)
- Knowledge of Microsoft Word, or equivalent word processing software
- Knowledge of Excel, or equivalent spreadsheet software
- Statistical analysis and data base searches
- Agile and Oracle experience
- Experience in the Medical Device Industry
- Lean manufacturing
- Expert working knowledge of US and International quality system regulations
- Proven project management skills
- Ability to complete technical projects with minimal supervision
- Strong interpersonal communication and teamwork skill
- Ability to understand and interpret drawings and data
- GD&T knowledge to interpret mechanical part drawings, assembly drawings, block and flow diagrams, and BOMs
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.