PAT_Quality Assurance Engineer Test
Billerica, MA10 days ago
- $6,700–$8,000 Per Month
- Full-time
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Skills
- Bioengineeringunmatched
- Blueprintsunmatched
- Communication Skillsunmatched
- Corrective and Preventative Action (CAPA) Systemsunmatched
- Design Failure Mode and Effects Analysis (DFMEA)unmatched
- Engineeringunmatched
- Failure Mode and Effects Analysis (FMEA)unmatched
- Geometric Dimensioning and Tolerancingunmatched
- Interpersonal Skillsunmatched
- Leadershipunmatched
- Lean Six Sigmaunmatched
- Materials Managementunmatched
- Mechanical Engineeringunmatched
- Medical Equipmentunmatched
- Microsoft Excelunmatched
- Microsoft Outlookunmatched
- Microsoft Wordunmatched
- Problem Solving Skillsunmatched
- Process Failure Mode and Effects Analysis (PFMEA)unmatched
- Product Developmentunmatched
- Product Testingunmatched
- Project/Program Managementunmatched
- Quality Engineeringunmatched
- Regulationsunmatched
- Risk Managementunmatched
- Team Playerunmatched
- Technical/Engineering Designunmatched
Description
Job Summary:
- 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.
Numbers & Facts
| Location | Boston, MA |
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