Quality Engineer, Advanced Technologies

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 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.

• 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
• Knowledge of Solid Works 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
• Detail oriented
• Good decision-making skills and judgement

Education and Experience

• Minimum 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, preferably in spine or orthopedic medical devices

CERTIFICATES, LICENSES, REGISTRATIONS

ASQ CQE (Certified Quality Engineer) preferred

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…