- Bachelor's Degree or equivalent in Engineering or Scientific field, 2 years of experience related to work experience required; or Master's Degree or equivalent in Engineering or Scientific field, 1-year experience including either industry or industry/education required.
- Proficient with the Microsoft Office suite
- Experience with medical device complaint investigations (CAPA's, NCR's, and Root-Cause Analysis)
- Functional, physical, and visual testing of medical device equipment in a laboratory setting
- 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.
- Preference is for candidates to have some complaint investigation experience/root cause analysis. Another preference is for medical device experience.
- 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
- 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.
- 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).
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Quality Engineer - Irvine, United States - TalentBurst
Description
Position: Quality Engineer II (Complaint Investigations), Req#: 6085-1
Location: Irvine, CA (100% onsite)
Duration: 3 Months Contract
Job 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. The role is not remote and will require a presence on campus.
This opening is with the THV quality engineering team. The team of 23 engineers and technicians handles about 80 to 100 complaints per week. As a member of this team, you will have the opportunity to interact with domestic and global medical teams/clients.
Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and the client's systems/procedures for device investigation and risk assessments of reported complaints from the field.
Education and Experience:
Additional Skills:
Roles and Responsibilities:
Assess reported events against established risk documentation for clinical and compliance risk(s) and escalate to Quality Management and Product Safety as needed.
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