Quality Engineer II
Job in
Carlsbad, San Diego County, California, 92008, USA
Listed on 2026-03-03
Listing for:
Atec Spine
Full Time
position Listed on 2026-03-03
Job specializations:
-
Engineering
Quality Engineering, Manufacturing Engineer, Process Engineer
Job Description & How to Apply Below
Essential Duties and Responsibilities
* Support New Product Development as primary QE for mechanical implants and instruments. Manage multiple concurrent major and minor projects.
* Support Design Controls to ensure efficient, effective, and compliant new product launches.
* Support the qualification of legal manufacturers (OEM) for distributed products.
* Lead Material Review Board (MRB), own Non-Conformance (NC) development and resolution, lead reworks and deviations, participate in Supplier Review Board (SRB).
* Develop inspection plans and custom gauging based upon required measurement and tolerances.
* Support Change Order review for drawings, considering Design for Manufacturing (DFM) and Design for Inspection (DFI).
* Act as liaison between supplier and company for quality related concerns or issues. Technical interface with contract manufacturers.
* Support cleaning and sterilization validations of implantable devices; basic understanding of tests such as bioburden, BET, and dose audit testing.
* Support validation (IQ, OQ, and PQ) development and execution internally and at suppliers.
* Apply statistical techniques to analyze manufacturing processes and recommend appropriate process controls.
* Support Risk Management efforts in accordance with ISO 14971; conduct preliminary risk assessments for projects. Support Failure Mode and Effects Analysis (FMEA) for designs and processes.
* Support Field Retrieval Assessment (FRA) and Health Hazard Evaluation (HHE) as needed.
* Support MDSAP, FDA, ISO, and other regulatory audits.
* Apply external standards and guidance documents to project / product specific application.
* Own Supplier Corrective Actions (SCARs) and Corrective and Preventive Actions (CAPAs).
* Lead supplier part qualification for new products including process qualifications (PQs), GR&R, first articles, and process development.
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