Bachelor's or advanced degree in Mechanical Engineering or Bioengineering
Responsibilities
Conduct process verifications and validations
Perform FMEA for design or process
Read blueprints and apply inspection methods
Manage project priorities with onsite team
Collaborate with leadership on long-term strategies
Execute risk management and product testing
Implement quality systems in compliance with regulations
Benefits
Collaborative work environment
Opportunities for professional growth
Flexible working arrangements
Access to advanced training and development
Engagement with cutting-edge medical technologies
Full Job 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.
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.
