What are the responsibilities and job description for the Senior Engineer position at Jobs via Dice?
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We are looking for Senior Engineer for our client in Irvine, CA
Job Title: Senior Engineer
Job Location: Irvine, CA
Job Type: Contract
Job Description:
Pay Range: $54.57hr - $59.57hr
We are looking for Senior Engineer for our client in Irvine, CA
Job Title: Senior Engineer
Job Location: Irvine, CA
Job Type: Contract
Job Description:
Pay Range: $54.57hr - $59.57hr
- The Quality Engineer will be responsible for investigating complex manufacturing product quality and compliance issues, executing complaint investigations, and ensuring adherence to applicable procedures and regulatory standards.
- This role includes leading post-market surveillance activities, supporting risk management documentation, and collaborating across departments to drive quality improvement initiatives.
- Investigate complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) using sound engineering principles.
- Analyze investigation results, develop reports, and make actionable recommendations.
- Execute complaint investigations using a structured, multidisciplinary approach.
- Lead post-market surveillance activities for EU-approved products.
- Oversee all complaint investigations and ensure timely completion through all phases.
- Work closely with complaint investigation owners to resolve overdue issues and ensure compliance.
- Ensure complaint investigations are thorough and meet procedural requirements.
- Develop, update, and maintain the technical content of risk management files.
- Support leadership with other assigned quality-related tasks.
- Proficiency in Microsoft Office Suite (including MS Project) and electronic quality management systems.
- Strong documentation, communication, and interpersonal skills, including relationship management abilities.
- Basic understanding of statistical techniques.
- Detail-oriented team player with strong problem-solving, analytical, and critical thinking skills.
- Solid understanding of engineering principles, processes, and equipment.
- Strong leadership and change management abilities.
- Knowledge of applicable FDA regulations within the medical device industry.
- Excellent organizational skills with strict attention to detail.
- Ability to interact professionally with all organizational levels.
- Capable of managing multiple priorities in a fast-paced environment.
- Collaborative mindset with experience working in cross-functional teams.
- Commitment to health, safety, and environmental protocols.
Salary : $55 - $60
