Quality Engineer, Advanced Technologies

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.If you would like to know a bit more about this opportunity, or are considering applying, then please read the following job information.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 processesSupport verification, and validation activities; Support test tool and method development, test documentation, test part management, and test traceabilitySupport quality planning and inspection activities; Develop inspection plans and custom gauging based upon required measurement and tolerancesSupport 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 implementationSupport statistical studies to analyze data and recommend appropriate controls for ensuring product and process conformance to specificationProvide subject matter expertise for NCRs, CAPAs, and complaints, inclusive of associated risk assessments, to support business prioritiesTroubleshoot 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 manufacturingOther duties as assignedRequirementsThe 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 equipmentKnowledge of SPC, DOE, probability and statisticsAbility to read, analyze, and interpret blueprints, including GD&TAbility 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 findingsAbility to troubleshoot and manage priorities across multiple projectsStrong technical writing skills, including ability to write protocols, reports, and proceduresAbility to effectively interact with all levels of the organizationAbility 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 teamworkDemonstrates tenacity in overcoming obstacles; proactive in taking initiativeKnowledge of SolidWorks or other CAD software preferredManufacturing Engineering experience preferred, including knowledge of metal part production and processing. Process knowledge including milling, turning, EDM, and secondary processingDetail orientedGood decision-making skills and judgement Education and ExperienceMinimum 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 devicesCERTIFICATES, LICENSES, REGISTRATIONSASQ CQE (Certified Quality Engineer) preferredFor 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. xhyhwjd Salary RangeAlphatec 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. $75,000 to $90,000 Full-Time Annual SalaryBenefitsHealth Care Plan (Medical, Dental & Vision)Retirement Plan (401k, IRA)Life Insurance (Basic, Voluntary & AD&D)Paid Time Off (Vacation, Sick & Public Holidays)Family Leave (Maternity, Paternity)Short Term & Long Term DisabilityFree Food & SnacksStock Option Plan