36 Quality Engineer (THV) @Irvine, CA Jobs in Irvine, CA
intellectt is Hiring a Quality Engineer (THV) @Irvine, CA Near Irvine, CA
- 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.
- Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures for device investigation and risk assessments of reported complaints from the field.
- 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 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 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).
- Bachelor's Degree or equivalent in Engineering or Scientific field, 2 years’ experience related work experience required; or Master's Degree or equivalent in Engineering or Scientific field, 1 year experience including either industry or industry/education 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.
- 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
Job Summary
Full Time
Business Services
$107k-126k (estimate)
06/05/2024
09/11/2024
intellectt.com
ISELIN, NJ
200 - 500
2018
KIRAN MADALA
$5M - $10M
Business Services
Related Companies
About intellectt
Intellectt Inc. was founded to set a new standard in Consulting and Staffing Industry. Our company is made up of dreamers, calculated risk-takers, diligent people that go to fight for the brand of our client. Intellectt Inc. and our affiliated brands provide innovative talent solutions that make our clients businesses better. Our verticals include Healthcare and IT. We exist to become the finest and most esteemed staffing company across the USA and we look forward to putting our talents to use to push your organization forward.
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