Sustaining Quality Engineer II, AIX
Sustaining Quality Engineering role with a focus on electro-mechanical systems, software products, information systems. The Quality Engineer will work closely with R&D, Marketing, Supply Chain, and Regulatory to support ATEC processes and Alpha Informatix products while ensuring compliance to applicable standards and regulations.
Essential Duties and Responsibilities- Provides subject matter expertise for related Alpha Informatix Support Tickets, NCRs, CAPAs, complaints and servicing
- Supports product and process changes for qualification and validation requirements; supports change implementation
- Supports inspection activities, ensuring results and documentation support the recommended disposition
- Supports software testing; Understands test tools and methods, test documentation, test management, test traceability, defect management and tracking
- Supports routine sterilization monitoring activities including, but not limited to dose audit, bioburden, BET
- Supports risk management activities in accordance with ISO 14971
- Supports cybersecurity activities including, but not limited to incident response and vulnerability management
- Provides statistical support to analyze data and recommend appropriate controls for ensuring conformance to specification
- Troubleshoots and drives efficiency, cost savings and continuous process and quality improvements through application of six sigma, 5S, and lean manufacturing
- Maintains regular and consistent attendance at the normal worksite
- 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.- Understanding of the FDA Quality System Regulations (21 CFR Part 820) & (ISO 13485:2016)
- Understanding of IEC 62304, ISO 14971, ISO 10993, ISO 11137, and ISO 11135 requirements
- Understanding of Medical Device Single Audit Program (MDSAP) requirements
- Working knowledge of biocompatibility requirements, SPC, DOE, probability and statistics
- Prior successful testing and validation of medical products through full life cycle including writing protocols, reports, and procedures strongly preferred
- Know FDA and ISO requirements, how to conduct thorough validations.
- Ability to demonstrate technical expertise and effectively communicate with internal and external customers and executive management.
- Must be deadline-oriented, an effective communicator, and able to work within a team environment.
Education and Experience
Bachelor’s degree from four-year College or university in Engineering, Computer Science, or equivalent experience. 2-8 years of experience required.
ASQ CQE (Certified Quality Engineer), ASQ CSQE (Certified Software Quality Engineer), ASQ CQA (Certified Quality Auditor) 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 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. $85,000 to $95,000 Full-Time Annual Salary