Alphatec Spine
Medical Devices
QualityEngineer,AdvancedTechnologies
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“Quality Engineer, Advanced Technologies at Alphatec Spine. Skills: Quality Engineering, FDA Quality Management System Regulations, ISO 13485, Risk Management (ISO 14971), FMEA, Verification and Validation, Statistical Analysis, CAPA. Develop, improve, and implement quality methods and systems. Support design controls activities for surgical instruments”
What You'll Achieve.
Ensure the safety, reliability and efficacy of products and processes; Efficient, effective, and compliant new product launches; Ensure product and process conformance to specification; Support business priorities
Industry & Context.
Ability to solve complex problems to root cause and prevent re-occurrence (CAPA); Troubleshoot; Analyze data; Interpret data trends; Make basic recommendations based on findings
Must be eligible for and maintain credentials at all required hospitals, including meeting any applicable physical requirements or vaccination requirements (including the COVID-19 vaccine, as applicable) for roles based in the United States that require access to hospital facilities
What They're Looking For.
Must Have
Bachelor's degree (BS) from a four-year college or university, preferably in Mechanical, Biomedical, or Manufacturing Engineering, 1-4 years of quality engineering experience, Familiarity with the FDA Quality Management System Regulations (21 CFR Part 820), Familiarity with ISO 13485: 2016, Knowledge of mechanical inspection methods and equipment, Knowledge of SPC, DOE, probability and statistics, Ability to read, analyze, and interpret blueprints, including GD&T, Ability to solve complex problems to root cause and prevent re-occurrence (CAPA), Ability to process data, interpret data trends, and make basic recommendations based on findings, Ability to troubleshoot and manage priorities across multiple projects, technical writing skills, including ability to write protocols, reports, and procedures, Ability to effectively interact with all levels of the organization, Ability to develop and maintain working relationships with internal and external customers and suppliers, Excellent verbal and written communication, ability to resolve minor conflicts, collaborative teamwork, Demonstrates tenacity in overcoming proactive in taking initiative, Detail oriented, Good decision-making skills and judgement
Nice to Have
Knowledge of SolidWorks or other CAD software preferred, Manufacturing Engineering experience preferred, including knowledge of metal part production and processing, Process knowledge including milling, turning, EDM, and secondary processing, ASQ CQE (Certified Quality Engineer) preferred
What You'll Do.
and implement quality methods and systems
Support design controls activities for surgical instruments
Support risk management activities
Support Failure Mode and Effects Analysis (FMEA)
Support verification and validation
Support test tool and method development
Support quality planning and inspection
Develop inspection plans and custom gauging
Support Change Order review
Support design transfer
Support product and process changes for qualification and validation
Support statistical studies to analyze data
Provide subject matter expertise for NCRs
Troubleshoot and drive efficiency in new and ambiguous processes
Support cost savings and continuous process and quality improvements
How You'll Work.
Team & Collaboration
Working on cross functional teams; Act as liaison between supplier and ATEC for quality related concerns or issues; Technical interface with contract manufacturers; Effectively interact with all levels of the organization; Develop and maintain working relationships with internal and external customers and suppliers
Communication Scope
Excellent verbal and written communication; Ability to resolve minor conflicts
Process & Methodology
Manage priorities across multiple projects
Full Job Description
Quality Engineering role with a focus on instrumentation for use with electro-mechanical systems. 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 design controls activities for surgical instruments used with Informatix systems to ensure efficient, effective, and compliant new product launches including, but not limited to development planning, requirements specifications, verification and validation * Support risk management activities in accordance with ISO 14971, conduct preliminary risk assessments for projects. * Support Failure Mode and Effects Analysis (FMEA) for designs and processes * Support verification, and validation activities; Support test tool and method development, test documentation, test part management, and test traceability * Support quality planning and inspection activities; 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) * Support design transfer activities; Act as liaison between supplier and ATEC for quality related concerns or issues. Technical interface with contract manufacturers * Support product and process changes for qualification and validation requirements; support change implementation * Support statistical studies to analyze data and recommend appropriate controls for ensuring product and process conformance to specification * Provide subject matter expertise for NCRs, CAPAs, and complaints, inclusive of associated risk assessments, to support business priorities * Troubleshoot and drive efficiency in new and ambiguous processes; Support cost savings and continuous process and quality improvements through application of six sigma, 5S, and lean manufacturing * Other duties as
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