Quality Engineer I
$50,700–$101,300 year
On-site · Liberty, South Carolina, United States
Job Summary
Quality Engineer I role in Liberty, SC, responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support. Lead the implementation of process control systems, CAPA, and risk analysis; design and conduct experiments for process optimization; document experiment plans and results; lead CTQ parameter monitoring and product/process improvements (Six Sigma, Lean); investigate and prevent non-conformances; participate in cross-functional teams to support QMS, EMS, and regulatory requirements (FDA, ISO 13485, ISO 14971); collaborate with design engineering and microbiology, and contribute to verification/validation activities. This role requires a BS degree in engineering or a related field and typically 0-2 years of experience for entry-level, with preference for additional engineering experience and quality tools expertise.
Required Qualifications
- BS degree in Engineering or Technical Field
- Minimum 2 years of engineering experience (preferred)
- Experience with FDA, GMP, ISO 13485, ISO 14971
- ASQ CQE or other certifications preferred
- Strong communication and interpersonal skills
- Project management and leadership experience
- Ability to work in a matrixed, fast-paced environment
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