complaints investigations/post market surveillance
complaints investigations/post market surveillance
Intellectt Inc
Irvine, CA
See who Intellectt Inc has hired for this role
Role: Engr II
Location: Irvine, CA - 92614
Duration: 6 Months
Job Description
Location: Irvine, CA - 92614
Duration: 6 Months
Job Description
- Perform customer complaints investigations, providing detailed analysis of the process and the data; determine root causes of the nonconformities in order to establish corrective and preventive actions.
- Execute complaint investigations multifunctional approach and issues addressed in a systematic, methodical manner.
- Oversight of all complaints that require investigation through the different phases.
- Ensure on time completion of complaints.
- Work closely with complaint investigation owners to resolve issues and ensure those that have passed their due dates are addressed.
- Ensure complaint investigations are adequate and comply with applicable procedures.
- Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.
- Please refer to the job description for additional details.
- Investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.
- Optimize to optimize moderately complex Manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement.
- Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk
- Develop, update, and maintain technical content of risk management files
- Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes
- Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
- Other incidental duties assigned by Leadership
- Bachelor's Degree in in Engineering or Scientific field, 2 years years experience related work experience Required or
- Master's Degree or equivalent in and internship, senior projects or thesis in Engineering or Scientific field including either industry or industry/education Required
-
Seniority level
Entry level -
Employment type
Full-time -
Job function
Legal -
Industries
Staffing and Recruiting
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