Description: The Associate 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:
oDevelops and executes plans for quality and control to ensure manufacturing continuity and product conformance.
oLeads investigations into production and customer-facing quality issues to identify root cause, implement corrective and preventative actions, and monitor effectiveness
oMonitors and analyses product performance of medical devices using a statistical and risk-based approach. Considers any quality, compliance, customer, and business risks.
oPerforms hands-on troubleshooting of customer returned devices and manufacturing nonconformities and completes associated technical documentation
oDevelops tools to communicate complex technical problems and solutions to a variety of audiences within the organization
oProficient in project management, data analysis, root cause analysis, communication, and risk determination
oEnsure 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.
Top 3 must-have skill sets: Cross functional communication skills (will be working with all teams), Critical thinking (allows for quick on the spot thinking and ways to navigate unfamiliar issues), prioritization (this position will pull you in all directions so knowing what is important is key)
"Years of experience required: 0-2 years of experience in Medical Device /Pharmaceutical regulated industry.
"Specific education requirements: Minimum - Bachelor s Degree with Engineering or Physical Science Coursework,
"Preferred - Bachelor s or Master s Degree in Engineering with 0-3 years experience in Medical Device /Pharmaceutical regulated industry. ASQ Certification (e .g. CQA, CQE, CQM )
Custom Fields:
Name: System Access Required
Value: Yes
Name: Invoice Type
Value: USA-ARL-Staffing-USD
Name: Supervisory Org
Value: Quality Operations(Chris Rodriguez)-60004997
Name: Work Desk Phone Number Required
Value: No
Name: Badge ID Required
Value: Yes
Name: Workspace
Value: None
Name: Worker Time Type
Value: Full Time
Name: Remote Worker
Value: No