Sr Engineer

Irvine, CA, US • Posted 60+ days ago • Updated 5 hours ago

Full Time

On-site

Fitment

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Job Details

Skills

FOCUS
Quality Assurance
Manufacturing
Regulatory Compliance
Corrective And Preventive Action
Auditing
Surveillance
Risk Management
Microsoft Office
Quality Management
Documentation
Communication
Relationship Management
Conflict Resolution
Problem Solving
Analytical Skill
Critical Thinking
Leadership
Medical Devices
Attention To Detail
Management

Summary

Job Description:
The main function of a Sr Engineer in this quality role is to focus on implementing and optimizing quality engineering practices related to Complaints Investigation, Post Market Surveillance and Risk Management while ensuring a culture of quality and compliance with global regulatory requirements.
Responsibilities:

Investigate complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) based on engineering principles; analyze results, make recommendations and develop reports.
Execute complaint investigations multifunctional approach and issues addressed in a systematic, methodical manner.
Lead Post Market Surveillance activities for products approved in EU.
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.
Develop, update, and maintain technical content of risk management files.
Other incidental duties assigned by Leadership.

Requirements:

Bachelor's degree in engineering required.
5-7 years' experience required.
Proven expertise in usage of MS Office Suite including MS Project; Electronic Quality Management System.
Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills.
Basic understanding of statistical techniques.
Team player and detail oriented.
Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering.
Strong problem-solving, organizational, analytical and critical thinking skills.
Substantial understanding of processes and equipment used in assigned work.
Good leadership skills and ability to influence change.
Knowledge of applicable FDA regulations for medical device industry.
Strict attention to detail.
bility to interact professionally with all organizational levels.
bility to manage competing priorities in a fast-paced environment.
Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects.
dhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: dd53abae1587b1509e767f987c344f97
Posted 30+ days ago

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