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.
Roles & Responsibilities:
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.
Education & Experience:
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
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
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