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Quality Engineer II - Exempt

Lancesoft

Memphis, TN

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JOB DETAILS
SALARY
$45
SKILLS
Agile PLM / Oracle PLM (Product Lifecycle Management), Analysis Skills, Code of Federal Regulations, Communication Skills, Computer Software, Corrective Action, Equipment Validation, FDA (Food and Drug Administration), Failure Analysis, ISO (International Organization for Standardization), International Electro-Technical Commission (IEC), Manufacturing, Medical Equipment, Microsoft Access Database, Microsoft Excel, Microsoft Office, Microsoft PowerPoint, Microsoft Windows Operating System, Microsoft Word, Organizational Skills, Process Development, Process Failure Mode and Effects Analysis (PFMEA), Process Validation, Quality Assurance, Quality Engineering, Quality Metrics, Root Cause Analysis, SAP PLM, Software Validation, Spreadsheets, Statistics, System Validation, Technical Writing, Testing
LOCATION
Memphis, TN
POSTED
18 days ago

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

About the Company

L

Lancesoft

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc). 

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

COMPANY SIZE
2,000 to 2,499 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
2000
WEBSITE
http://www.lancesoft.com/

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