KH
Quality Engineer
Katalyst Healthcares & Life Sciences
🇺🇸 United States
On-site
3 months ago
- Risk Management
- FMEA
- GD&T
- CAPA
- Microsoft Word
- Excel
- Outlook
- Six Sigma
- Lean
3 months ago
- Seeking a Quality Engineer with 5+ years of experience in the medical device industry to support process verifications/validations, design quality engineering, design controls, risk management, and quality systems.
- The ideal candidate should have strong problem-solving, collaboration, and project leadership skills, with experience in Design/Process FMEA and product testing.
- Conduct Process Verifications/Validations.
- Perform Design and/or Process Failure Modes and Effects Analysis (FMEA).
- Perform blueprint reading, inspection methods, and GD&T.
- Ensure smooth implementation by working with the onsite team and managing project priorities.
- Collaborate with senior leadership on long-term strategy for the area/site.
- Perform risk management and execute product testing.
- Work on Quality Systems, including CAPA, nonconforming materials, risk management, and medical device regulations.
- Communicate effectively in both written and verbal formats and utilize Microsoft Word, Excel, and Outlook.
- 5+ years of work experience in the medical device industry.
- Experience conducting Process Verifications/Validations.
- Experience conducting Design and/or Process Failure Modes and Effects Analysis (FMEA).
- Design Quality Engineering experience.
- Design Control experience.
- Excellent problem-solving and decision-making skills.
- Strong interpersonal, collaboration, initiative, and project leadership skills.
- Advanced degree.
- Bachelor's degree in Mechanical Engineering or Bioengineering.
- New Product Development experience.
- Experience with blueprint reading, inspection methods, and GD&T.
- Strong experience with Design Excellence, Six Sigma, or Lean.
- Spanish as a second language.
Quality Engineer · Katalyst Healthcares & Life Sciences