Location:
Irvine, CA
Schedule:
Standard Office Hours
Duration:
12-Month Contract
Pay Range:$53.00 - $58.00/hour
Job Description
Summary:
The Senior Quality Engineer will focus on implementing and optimizing quality engineering practices related to complaints investigation, post-market surveillance, and risk management. This role ensures compliance with global regulatory requirements while fostering a culture of quality across all product lines.
Job Responsibilities
In this role, you will manage and support a variety of projects within the Quality Engineering department. Key responsibilities include:
- Investigate complex manufacturing quality and compliance issues (e.g., CAPA, non-conformances, audit observations) based on engineering principles.
- Execute complaint investigations using a multifunctional, systematic approach to resolve issues effectively and in compliance with procedures.
- Lead post-market surveillance activities for approved products, ensuring all complaints are properly tracked and completed on time.
- Develop, update, and maintain technical content for risk management files.
- Collaborate with investigation owners and cross-functional teams to address overdue cases and enhance investigation quality.
- Analyze data, make recommendations, and generate detailed reports based on investigation findings.
- Identify and implement opportunities for process improvements and efficiency within quality systems.
Knowledge & Skills
- Strong documentation, communication, and interpersonal relationship skills.
- Proficiency in Microsoft Office Suite (including MS Project) and electronic quality management systems.
- Fundamental understanding of statistical techniques and engineering principles.
- Strong problem-solving, analytical, and critical-thinking skills.
- Familiarity with FDA regulations and quality system requirements for medical devices.
- Ability to manage multiple priorities and work effectively in fast-paced environments.
- Excellent collaboration skills with the ability to influence and lead change.
- Strict attention to detail and adherence to company safety and compliance protocols.
Education & Experience
- Bachelor’s degree in Engineering required.
- 5–7 years of relevant experience.
- Experience in the medical device industry preferred.
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