Qa Compliance Specialist - (Multiple Location Around Usa)

Role: QA complaints investigation II

Location: Irvine, CA, Temecula, CA, Alameda, CA, North chicago IL

Duration: 12 Months

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.

Key Responsibilities

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

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