Sustaining Quality Engineer, Imaging

The Sustaining Quality Engineer, X-Ray Devices, is responsible for supporting the development and maintenance of Quality Management Systems for X-Ray Devices.  This role will support Intercompany installation teams that perform new X-Ray device installations and planned or corrective maintenance of supplied devices.   

• Be an expert in the field of quality and quality strategy for standards and regulations related to X-Ray devices in the US and outside of the US based on local and regional applicable standards and regulations, including but not limited to 21 CFR Part 1020 and 21 CFR Part 820, for the management of X-Ray emitting inventory and associated processes.  Perform and assist business customers with root cause and corrective action training, perform NCR process mentor training, confirm metric accuracy with business (quality focused) and implement common failure modes in eQMS software for extracting data and performing analysis / trending, assess corrective action requirements and present data to supply base. Ability to communicate actions needed identified through data analysis.  Provide conclusions to internal customers.  
• Identification and implementation of critical to quality KPIs including but not limited to product performance trending, supplier communication corrective actions. Executing and project management of corrections and improvements.  Identify signals of negative trends and take appropriate action to contain and correct.
• Additional responsibilities include owning supplier engagement and communication to assist with non-conforming products and/or processes through NCR processes, measuring internal process and supplier performance through product monitoring of installation of X-Ray components and devices including first yield pass, time to failure analysis, intercompany communication with direct and indirect interdepartmental customers to provide information on product performance, provide Quality Engineering support for Operations (related to installations and preventive/corrective actions for X-Ray devices).  Identify thresholds to establish corrections that feed back into Quality processes establishing constant improvement.  Create or modify systems needed for output and analysis.  Provide guidance or execute training on QMS processes when required.  
• Quality liaison between Installation and Maintenance teams and the internal organizations including Quality, Development, Operations and Purchasing.

Essential Duties and Responsibilities

• Generate, own, and review project work, set work and resourcing priorities, and review/course correct the output of project deliverables.
• Implement data collection system for relevant metrics integrated within ATEC Quality Objectives.
• Implement forum for ongoing technical training related to X-Ray emitting medical devices to match needs of the business.
• Work closely with our Business Systems team to ensure the quality management system continuous improvement initiatives are met. 
• Able to effectively determine failure mode root cause and interpret root cause analysis; implement corrective actions effectively. 
• Perform data analysis and create or modify systems and tools used for measuring and monitoring of product and processes.
• Lead continuous improvement projects for QMS systems.
• Ensure all procedures reflect department practices and regulatory compliance.
• Maintain a state of audit readiness of all related processes.
• Facilitate resolution of problems, issues and/or risks; establish risk where required.  
• Identify current state of processes, including roles/responsibilities and inputs/outputs (handoffs), through cross functional input and independent research.
• Perform gap analysis to analyze and work within the organization to define changes necessary to improve results through root cause analysis determination and trending.
• Draft and release procedures, work instructions and training curriculum. Lead periodic and recurring training sessions to support implementation of processes.
• Provides statistical support to analyze manufacturing processes and to recommend appropriate process controls for ensuring product conformance to specification.  
• Participates in FDA, ISO/MDSAP and internal audits.
• Performs other duties as assigned.
  

Requirements

The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Technical Qualifications:
• Firm Understanding of the FDA Quality System Regulations (21 CFR Part 820), ISO 13485, and Diagnostic X-Ray systems and their major components (21 CFR Part 1020.30 and referenced regulations contained).
• Understanding of QMS systems, design and structure, to meet output needs and data extraction.  Ability to partner with respective teams to modify systems where required.  
• Extensive ability to analyze blueprints and design/assembly specifications.  
• Highly proficient in Technical Writing (Protocols, Repots)
• General knowledge of SPC, DOE, probability, and statistics

Management:

• Project management and communication with internal and external customers.

Education and Experience

• Minimum Bachelor’s degree (BS) from a four-Year College or university in an Engineering discipline, or minimum 5 years’ experience in a related function.  

For roles based in the United States that require access to hospital facilities, 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).

ATEC is committed to providing equal employment opportunities to its employees and applicants without regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, gender expression, or any other protected status in accordance with all applicable federal, state or local laws. Further, ATEC will make reasonable accommodations that are necessary to comply with disability discrimination laws.

Salary Range

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-$105,000 Full-Time Annual Salary Range