Quality Assurance Specialist
4 weeks ago
Job Description:
The Quality Engineer is responsible for supporting sustaining activities through the application of Quality Engineering skills for medical devices. This person will understand, improve, and control operational processes to realize predictable product flow while satisfying established Client standards of quality.
This position is responsible to build sound technical and organizational competence within area of responsibility. Ensure the systems comply with applicable government regulations and standards.
Key Responsibilities:
- Support sustaining activities through the application of Quality Engineering skills
- Understand, improve, and control operational processes
- Build sound technical and organizational competence
- Ensure systems comply with government regulations and standards
Requirements:
- B.S. degree in Engineering (Industrial, Mechanic) Desired
- 3+ Years Quality experience including Validation and Quality Engineering responsibilities
- Demonstrate success with statistical and problem-solving methodologies
- Excellent knowledge of the principles for Quality Engineering and Quality management as related to validation process on medical devices
- Strong understanding of failure analysis, test methods and engineering tolerances
- Strong verbal, written and interpersonal skills
- Proficient with Minitab or other statistical software, MS Word, Excel, and MS project
- Six Sigma Certification Desired: ASQ CQE
- Working knowledge of 21CFR820, ISO 13485
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