Quality Engineer Ii Jobs

Job Title:QualityEngineerII

Pay Rate: $44.17to55.21/Hr

Duration:6 Months

Location:Orange County, CA(Onsite)

We are looking for aQualityEngineerII.

:

• This position will be inTHV 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 our systems/procedures for device investigation and risk assessments of reported complaints from the field.

Key Responsibilities:

• Investigate complex manufacturing product quality andcompliance issuesreported from the field, analyze results, determine root cause/probable cause, and initiate and review reports.
• Assess reported events against established risk documentation for clinical and compliance risk(s) and escalate to Quality Management and Product Safety as needed.
• Identify and report key complaint metrics per device category and collaborate with applicable manufacturing engineering teams to resolve production/device-related issues.
• 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) andCorrective/Preventive action(s) – CAPAs, SCARs, as determined by the investigation.
• Other incidental duties assigned by Leadership (May assist in Adhoc complaint analysis or metric review).

Must have skills:

• Functional, physical, and visual testing of medical device equipment in a laboratory setting
• Proficient with the Microsoft Office suite
• Experience withmedical device compliant investigations (CAPA's, NCR's, Root-Cause Analysis)

Education and Experience:

• Experience in complaint investigations,root cause analysis, and the associated risk assessments preferred.
• Experience inmedical devices(cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment preferred.
• 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.

Additional Skills:

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

Must have skills:

• Experience withmedical device-compliant investigations (CAPAs, NCRs, Root-Cause Analysis)
• Functional, physical, and visual testing of medical device equipment in a laboratory setting
• Proficient with the Microsoft Office suite
• The preference is for a candidate to have some complaint investigation experience/root cause analysis. Another preference is for medical device experience.