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Our mid-sized medical device client is adding a Sustaining Quality Engineer to support operations and project teams by providing statistical and technical support through direct testing of products and processes to ensure consistent customer requirement fulfillment.
Your role with the company:
- Focus on existing product line maintenance and continuous improvement.
- Implement and maintain Statistical Process Control (SPC) to enhance in-process controls.
- Support manufacturing operations to ensure consistent product quality.
- Conduct periodic reviews of established processes and update control plans as needed.
- Collaborate with production teams to resolve quality issues in real-time.
- Develop and analyze in-process data to provide trend analysis, troubleshoot quality issues, and offer recommendations to internal and external customers.
- Drive quality-related investigations to resolution and manage associated quality system records (CAPA, NC, Complaint).
- Identify opportunities for improvement in systems and products within assigned areas.
- Other duties as assigned.
Desired Profile:
- Bachelor's degree (High School Diploma/GED minimum)
- Certified Quality Engineer (CQE) preferred
- Valid identification and the ability to work legally in the United States.
- 5+ years of experience, preferably in a Medical Device or Component manufacturing environment
- Excellent written and oral communication skills
- Problem-solving and critical thinking skills
- Proficiency in quality tools (PPAP, IQ, OQ, PQ, FMEA, Control Plans, DOE, GRR)
- Experience with quality management systems (ISO, AS, GMP)
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