Quality Engineer II
Aequor JD ·www.aequor.com
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Description: The Quality Engineer is responsible for maintaining quality and control of manufacturing processes and post-market performance of medical devices. Responsibilities include collaborating with internal and external stakeholders to achieve company objectives, leading technical root cause investigations, developing and executing risk-based decisions, resolving and documenting customer complaint and manufacturing investigations, and representing Quality in cross-functional projects.
Job Duties:
Develops and executes plans for quality and control to ensure manufacturing continuity and product conformance.
Leads investigations into production and customer-facing quality issues to identify root cause, implement corrective and preventative actions, and monitor effectiveness
Monitors and analyses product performance of medical devices using a statistical and risk-based approach. Considers any quality, compliance, customer, and business risks.
Performs hands-on troubleshooting of customer returned devices and manufacturing nonconformities and completes associated technical documentation
Develops tools to communicate complex technical problems and solutions to a variety of audiences within the organization
Proficient in project management, data analysis, root cause analysis, communication, and risk determination
Ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, and other worldwide regulatory agencies as pertaining to medical devices.
Minimum Requirements:
Bachelor s degree in Engineering
3 years of relevant experience in a regulated industry (manufacturing, medical device, or medical device manufacturing preferred)
Knowledgeable of FDA regulations, 21 CFR part 820 and Part 803 and ISO 13485 standard
Bachelor s degree in Engineering
Custom Fields:
Name: System Access Required
Value: Yes
Name: Supervisory Org
Value: Quality Operations - Sustaining Engineer 2(Kevin Bellows)-60000436
Name: Work Desk Phone Number Required
Value: Yes
Name: Remote Worker
Value: No
Name: Worker Time Type
Value: Full Time
Name: Invoice Type
Value: USA-ARL-Staffing-USD
Name: Workspace
Value: None
Name: Badge ID Required
Value: Yes
Job Duties:
Develops and executes plans for quality and control to ensure manufacturing continuity and product conformance.
Leads investigations into production and customer-facing quality issues to identify root cause, implement corrective and preventative actions, and monitor effectiveness
Monitors and analyses product performance of medical devices using a statistical and risk-based approach. Considers any quality, compliance, customer, and business risks.
Performs hands-on troubleshooting of customer returned devices and manufacturing nonconformities and completes associated technical documentation
Develops tools to communicate complex technical problems and solutions to a variety of audiences within the organization
Proficient in project management, data analysis, root cause analysis, communication, and risk determination
Ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, and other worldwide regulatory agencies as pertaining to medical devices.
Minimum Requirements:
Bachelor s degree in Engineering
3 years of relevant experience in a regulated industry (manufacturing, medical device, or medical device manufacturing preferred)
Knowledgeable of FDA regulations, 21 CFR part 820 and Part 803 and ISO 13485 standard
Bachelor s degree in Engineering
Custom Fields:
Name: System Access Required
Value: Yes
Name: Supervisory Org
Value: Quality Operations - Sustaining Engineer 2(Kevin Bellows)-60000436
Name: Work Desk Phone Number Required
Value: Yes
Name: Remote Worker
Value: No
Name: Worker Time Type
Value: Full Time
Name: Invoice Type
Value: USA-ARL-Staffing-USD
Name: Workspace
Value: None
Name: Badge ID Required
Value: Yes
Frequently asked questions
Who is hiring for the Quality Engineer II role?
Aequor JD is hiring for the Quality Engineer II position, a Shazamme client. Apply directly on the employer's career site.
Where is the Quality Engineer II job located?
The Quality Engineer II role with Aequor JD is based in Irvine, CA, US.
Is the Quality Engineer II role full-time or contract?
This is a full time position at Aequor JD.
What experience level is the Quality Engineer II role?
The Quality Engineer II position is aimed at mid-level candidates.
How do I apply for the Quality Engineer II role at Aequor JD?
Apply directly on Aequor JD's career page via the Apply button on this listing. ZammeJobs links straight through to the employer's ATS — no third-party form, no resume database.