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Quality Engineer II - Exempt
Job Description
Join our dynamic team in Memphis, TN, a city known for its rich cultural heritage and vibrant community. We are seeking a dedicated professional to assist with the implementation of new projects in a manufacturing environment. This role provides an excellent opportunity to work closely with senior engineers, develop processes, and ensure the highest quality standards are met.
Must Have
- 1-3 years of Medical Device industry experience
- Familiarity with FDA 21 CFR Part 820 and EU 217/745 (EU MDR)
- Knowledge of standards such as ISO 13485, ISO 14971, IEC 60601
- Proficiency in Microsoft Office Applications (Word, Excel, Access, and PowerPoint) and Windows OS
- Investigation and root cause analysis skills
- Technical writing knowledge
- Organization and communication skills
- Process Validation and Computer software validation knowledge
Responsibilities may include the following and other duties may be assigned:
- Assist with the creation and revision of work instructions
- Develop and execute validations
- Analyze failures to create corrective actions
- Revise pFMEA and work closely with Senior Engineers to develop processes
- Train users in new processes and equipment validations
- Work with multiple software systems including Microsoft Office, Agile PLM, and SAP
- Design or specify inspection and testing mechanisms and equipment
- Conduct quality assurance tests and perform statistical analysis
- Ensure corrective measures meet acceptable reliability standards
- 1-3 years of Medical Device industry experience, Familiarity with FDA 21 CFR Part 820, EU 217/745 (EU MDR), and standards such as ISO 13485, ISO 14971, IEC 60601
- Investigation and root cause analysis skills
- Process Validation, Equipment Validation, and Software/Spreadsheet validation knowledge
- Bachelor’s degree
- 2-5 years of relevant experience
- Work Schedule: 40 hours per week;1st shift
- Location: On-site in Memphis, TN
- Interview Timeline: As soon as possible
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LanceSoft is proud to announce that its Chief Executive Officer, Anju Abel, has been honored with the prestigious "Staffing Leader of the Year" award at the 2025 TIARA Staffing Awards US. The award recognizes her visionary leadership and significant contributions to improving staffing processes, employee engagement, and workforce outcomes.
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