Biomedical Quality Engineer - Irvine, United States - Infosoft, Inc.

Description

Job Title: Biomedical Quality Engineer

Pay Rate: $40 to $44.98/HR

Duration: 3 months

Location: Orange County, CA

Our Client is a Global medical device Manufacturer.

We are looking for Biomedical Quality Engineer I

Description:

• This position will be in THV Quality Engineering, Global Product Surveillance (GPS).
• The GPS team is responsible for leading and performing critical engineering investigations on globally reported complaints for returned/non-returned devices.
• Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and our systems/procedures for device investigation and risk assessments of reported complaints from the field.

Responsibilities:

• Investigate complex manufacturing product quality and compliance issues reported from the field, analyze results, determine root cause/probable cause, and initiate and review reports.
• Perform hands-on device investigation using visual, dimensional, and test equipment to determine the root cause
• Assess reported events against established risk documentation for clinical and compliance risk(s) and escalate to Quality Management and Product Safety as needed.
• Participate in escalation tasks and activities, including Project Risk Assessments (PRA) and Corrective/Preventive action(s) – CAPAs, SCARs, as determined by the investigation.
• Identify and report key complaint metrics per device category and collaborate with applicable manufacturing engineering teams to resolve production/device-related issues.
• Other incidental duties assigned by Leadership (May assist in Adhoc complaint analysis or metric review).

Education and Experience:

• Bachelor's degree in engineering, 0 - 2 years experience related work experience required
• Experience in medical devices (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment preferred.
• Experience in complaint investigations, root cause analysis, and the associated risk assessments preferred.

Additional Skills:

• Good documentation, communication, and interpersonal relationship skills including negotiating and relationship management skills
• Basic understanding of statistical techniques
• Previous experience working with lab/industrial equipment required
• Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
• Solid problem-solving, organizational, analytical, and critical thinking skills
• Solid understanding of processes and equipment used in assigned work
• Knowledge of and adherence to Quality systems
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast-paced environment
• Must be able to work in a team environment, including the ability to manage project stakeholders
• Ability to build productive internal/external working relationships