More jobs:
Quality Engineer II
Job in
Carlsbad, San Diego County, California, 92011, USA
Listed on 2026-07-01
Listing for:
Alphatec Spine
Full Time
position Listed on 2026-07-01
Job specializations:
-
Engineering
Quality Engineering, Process Engineer -
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
Mechanical Quality Engineer
Mechanical Quality Engineer supporting new product development. Develop, improve, and implement quality methods and systems, working on cross functional teams in a regulated environment to ensure the safety, reliability and efficacy of products and processes.
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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