Quality Engineer II - Exempt

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

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

Top 3 Technical Skills Required

• 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

Education and Experience Required

• Bachelor’s degree
• 2-5 years of relevant experience

Additional Information

• Work Schedule: 40 hours per week; 1st shift
• Location: On-site in Memphis, TN
• Interview Timeline: As soon as possible