Quality Complaints Engineer
Company: CYNET SYSTEMS
Posted on: March 15, 2023
Pay Range: $44.70 - $49.70
- Investigate complex manufacturing product quality and
compliance issues reported from the field, analyze results,
determine root cause/probable cause, and initiate and review
- 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).
Education and Experience:
- 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
- Experience in medical devices (cardiovascular, endovascular, or
other critical care/surgical products), healthcare, or a related
- Experience in complaint investigations, root cause analysis,
and the associated risk assessments preferred.
- Good documentation, communication and interpersonal
relationship skills including negotiating and relationship
- Basic understanding of statistical techniques.
- Previous experience working with lab/industrial equipment
- Solid understanding and knowledge of principles, theories, and
concepts relevant to Engineering.
- Solid problem-solving, organizational, analytical and critical
- Solid understanding of processes and equipment used in assigned
- Knowledge of and adherence to Quality systems.
- Strict attention to detail.
- Ability to interact professionally with all organizational
- Ability to manage competing priorities in a fast-paced
- Must be able to work in a team environment, including the
ability to manage project stakeholders.
- Ability to build productive internal/external working
Keywords: CYNET SYSTEMS, Irvine , Quality Complaints Engineer, Engineering , Irvine, California
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