Quality Engineer, Advanced Technologies

Alphatec Spine•Carlsbad, CA

12h•Onsite

About The Position

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.

Requirements

Familiarity with the FDA Quality Management System Regulations (21 CFR Part 820), (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
Strong 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 strong 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 obstacles; proactive in taking initiative
Detail oriented
Good decision-making skills and judgement

Nice To Haves

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

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 assigned