Senior Quality Assurance Auditor
Medline Industries, LP
Validation Engineer III
Alphatec Spine
full-time
Posted on:
Origin: • 🇺🇸 United States • California
Visit company websiteSalary
💰 $107,000 - $117,000 per year
Job Level
Mid-LevelSenior
About the role
- Validation Engineering for New Product Development & Sustaining Engineering with a focus on software systems
- Leads design verification & validation activities for complex projects, ensuring deliverables meet quality, timeline, and compliance requirements, while providing clear direction to cross-functional teams
- Defines and executes comprehensive design verification and validation strategies for new product development, including authoring test plans and protocols, with an emphasis on developing processes in uncharted or ambiguous areas
- Drives innovation in verification & validation methodologies, developing advanced test methods, optimizing validation processes, and facilitating cross-functional problem resolution to achieve project goals
- Manual and automated system test method development and qualification
- Represents Quality Engineering when collaborating with designated personnel to develop various design controls documents per FDA guidance (General Principles of Software Validation), including but not limited to Requirements Specifications, Validation/Test Plan, Testing, Integration Test Scripts, Operational/System Test Scripts, and Validation Summary Reports
- Contributes to Risk Management efforts in accordance with ISO 14971
- Provides informal oversight and mentoring to less-experienced validation engineers
- Maintains regular and consistent attendance at the normal worksite
- Other duties as assigned
Requirements
- Proficient in FDA Quality System Regulations (21 CFR Part 820) & (ISO 13485:2016)
- Proficient in IEC 62304, IEC 60601 requirements
- Proficient in ISO 14971 requirements
- Understanding of ANSI C63:27 American National Standard for Evaluation of Wireless Coexistence requirements
- Experience with Test Case management software and ALM software (Polarion) is a plus
- Working knowledge of test method qualification methods (Gage R&R, Attribute Agreement Analysis) including competency using desktop lab equipment (function generators, oscilloscopes, etc)
- Working knowledge of Statistical Process Control (SPC), Design of Experiments (DOE), and probability and statistics preferred
- Prior successful testing and validation of medical products through full life cycle including writing protocols, reports, and procedures required
- Demonstrates comprehensive knowledge of project management techniques to ensure predictability of complex cross-functional projects
- Ability to demonstrate technical expertise and communicate with internal and external customers and executive management
- Must be deadline-oriented and detail-oriented, an effective communicator, and able to work within a team environment
- Bachelor’s degree in engineering or related field, with a minimum of six (6) years of medical device experience; OR Master’s degree in engineering or related field, with a minimum of five (5) years of medical device experience
- ASQ CSQE or CQE 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)
- Employer will not sponsor applicants for work visas for this position
