Description
Position Description:*Lead CAPA and NC program to ensure timely processing and closure.
*Use engineering principles to guide quality decisions such as statistical analysis or DOE to identify sources of variation affection products and processes and provide direction for CAPA or process improvement activities.
*Host or participate in MRB to ensure timely disposition and problem resolution.
*Guide IQC on resolving daily incoming, WIP, and final inspection issues.
*Perform quality system audits as requested or required.
*Establish quality inspection criteria and requirements including but not limited to generating SOPs and work instructions.
*Implement and improve methods of process control.
*Generate, analyze, maintain, and report quality metrics to QA Department and Sr. Management under the guidance of the Sr. QA Manager.
*Participate or lead Quality Circle projects sponsored by the Sr. Quality Manager and/or Operations.
*Knowledgeable in ISO 13485/QSR requirements.
Requirements:
EDUCATION / EXPERIENCE REQUIREMENTS: Minimum level of education/experience required.
* 4 year B.S. degree in Mechanical, Manufacturing, Quality Engineering, or relevant discipline.
* ASQ Certified Quality Engineer preferred.
* 3 - 4 years of related experiences.
* Must have medical device compliance experience.
SPECIALIZED SKILLS & OTHER REQUIREMENTS: Additional preferred or required qualifications.
* Sterilization validation desired.
* Experienced Lean Six-Sigma practitioner desired.
* ASQ Certified QE preferred.
* Must be able to interpret m