Alphatec Spine
Quality Engineer II
Carlsbad, California, United States · Mid · Full-time
No sponsorship$90k-$110kDetected 36 days ago
SolidWorksFDA RegulatoryMedical DevicesLeadershipCommunicationCollaborationWriting
About the role
- Mechanical Quality Engineer supporting new product development.
- Act as liaison between supplier and company for quality related concerns or issues.
- Technical interface with contract manufacturers.
Responsibilities
- 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).
- Support Change Order review for drawings, considering Design for Manufacturing (DFM) and Design for Inspection (DFI).
- 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.
- Support Risk Management efforts in accordance with ISO 14971; conduct preliminary risk assessments for projects.
Requirements
- Develop inspection plans and custom gauging based upon required measurement and tolerances.
- The requirements listed below are representative of the knowledge, skill, and/or ability required.
- Direct experience with implantable devices, instrumentation, and disposables in a regulated environment.
Compensation
- Alphatec Spine, Inc. complies with state and federal wage and hour laws and compensation depends upon candidate's qualifications, education, skill set, years of experience, and internal equity. $90,000 to $110,000 Full-Time Annual Salary
Benefits
- Support Field Retrieval Assessment (FRA) and Health Hazard Evaluation (HHE) as needed.
Visa & Work Authorization
- At this time, ATEC Spine does not sponsor employment visas for this position
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This listing is sourced directly from Alphatec Spine's careers page and normalized into a canonical job model.