Role OverviewThe Quality Engineer II will work in a design team setting, supporting new product development and design through design verification activity. They will develop risk assessment, inspection methodology, and acceptance criteria for inspection sample plans and conduct audits of new suppliers as part of project teams. They will provide leadership in understanding medical device regulations to other disciplines.
What You Will Do
Develop risk assessment, inspection methodology, and acceptance criteria for inspection sample plans. Conduct audits of new suppliers. Provide leadership in understanding medical device regulations.
Why It Might Be a Fit
The ideal candidate will have a minimum of 2 years of experience in Quality Engineering/Process Excellence/Lean. They will have excellent problem-solving, decision-making skills, and interpersonal skills that foster conflict resolution as it relates to technical situations.
Requirements
- Bachelor's degree in a Technical or Scientific discipline
- Minimum of 2 years of experience
- Quality Engineering/Process Excellence/Lean experience
- Conducting Process / Design Failure Mode Effects and Analysis
- Biomaterial and/or Mechanical product knowledge
- Blueprint reading/literacy including GD&T
- Familiarity with inspection methods and techniques
- Knowledge of the QSR, Design Controls, and ISO quality requirements
Benefits
- Consolidated retirement plan (pension)
- Savings plan (401(k))
- Long-term incentive program
- Vacation
- Sick time
- Holiday pay
- Work, Personal and Family Time
- Parental Leave
- Bereavement Leave
- Caregiver Leave
- Volunteer Leave
- Military Spouse Time-Off
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