Quality Assurance Specialist
4 weeks ago
At Intellectt Inc, we are seeking a highly skilled Quality Validation Engineer to join our team.
Key Responsibilities:
- Develop and implement quality validation processes to ensure compliance with regulatory requirements.
- Collaborate with cross-functional teams to identify and mitigate quality risks.
- Analyze data to identify trends and areas for improvement.
- Develop and maintain quality documentation, including procedures and reports.
- Provide training and support to colleagues on quality-related topics.
Requirements:
- 3+ years of experience in quality assurance, including validation and quality engineering responsibilities.
- Demonstrate success with statistical and problem-solving methodologies.
- Excellent knowledge of quality engineering and management principles, as related to validation processes 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.
- B.S. degree required.
- B.S. degree in engineering (industrial, mechanical) desired.
Interview Process:
Onsite interview and tour. Typically, one visit for interview and tour, but may do a second.
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