Tracking Code285-525 Job Description
Job LocationMesa, Arizona, United StatesPosition TypeFull-Time/Regular
Job Summary: This position will perform Quality Engineering functions and ensure full compliance of requirements for development, raw materials, components, finished goods, and post market quality with Software experience.
- Development, Review, and signature authority of internal QMS documents other duties
- Define the quality plan for new product development projects. Ensure alignment with cross functional team through concurrent engineering to complete the quality plan activities. Warrant execution and provide deliverables of those items contained and owned within the quality plan
- Provide input into the overall risk process including software, risk management plan, risk file, and risk report for new product development projects and sustaining change management projects (xFMEA)
- Support, perform and or approve testing as required through traceability to ensure requirements are verified and validated
- Support the analysis of cost of poor quality. Presenting vendor and supplier quality metric data.
- Ensure thorough investigation and execution of corrective and preventative actions associated with internal process, vendor, and audit findings
- Provide input in the approval of new vendors/suppliers
- Support product transfers and line qualification (IQ,OQ,PQ)
- Support customer service group on post market quality analysis and troubleshooting
- Lead and Guide other quality and operations engineers to support successful completion of projects
- Bachelor’s Degree in Computer Science or Computer Engineering or Electrical/Chemical/Mechanical Engineering with the appropriate software experience
- Understanding of IEC 62304 or DO-178B
- Understanding of CMMI and help company work towards level 5
- Understanding of design change management and configuration management
- Understanding of Risk Management (ISO14971) or Safety engineering
- Understanding of system software, firmware, and hardware integration (C, C++, Visual Basic, scripting languages such as Python)
- Development and validation of equipment and automated system
- Medical Device experience highly preferred, 21CFR820, ISO14971, ISO13485
- Six Sigma applications (DMAIC toolset)
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Position requires sitting for prolonged periods as well as stand for periods of time.
- The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Merz Device Innovation Center (Ulthera, Inc.) is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. EEO is the Law.