complaints / investigation Specialist @Irvine, CA
complaints / investigation Specialist @Irvine, CA
Intellectt Inc
Irvine, CA
See who Intellectt Inc has hired for this role
Role: Engr II
Location: Irvine, CA - 92606
Duration: 8 Months
Space Designation: Onsite = dedicated workspace & at least 80% onsite
Job Description
Location: Irvine, CA - 92606
Duration: 8 Months
Space Designation: Onsite = dedicated workspace & at least 80% onsite
Job Description
- Perform Post Market 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 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 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.
- 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
- Proficient at MS Suite, especially Excel and PowerPoint
- Experience with Power BI
- Understanding of data trending and analytics, data pulls/refresh data sources
- Post market surveillance experience
- Complaints
- FCA
- PRA
- CAPA
- Understanding of regulations, a plus; EUMDR, FDA, ISO standards
- Medical device experience
- Excellent writing skills
- Ignite preferred
- ETQ (Reliance) experience preferred
- Bachelor's Degree in in Engineering or Scientific field including either industry or industry/education, minimum of 2 years' experience Required OR
- Master's Degree or equivalent in in Engineering or Scientific field including either industry or industry/education Required or internship, senior projects, or thesis Required
-
Seniority level
Associate -
Employment type
Full-time -
Job function
Legal -
Industries
Medical Equipment Manufacturing and Pharmaceutical Manufacturing
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