Quality Assurance Engineer confidential
Memphis, TN14 days ago
Highlights
Join our dynamic team in Memphis, TN, a city known for its rich cultural heritage and vibrant community. Work with multiple software systems including Microsoft Office, Agile PLM, and SAP.
Numbers & Facts
| Location | Memphis, TN |
| Industry | Staffing/Employment Agencies |
| Salary | $45 |
| Company Size | 2,000 to 2,499 employees |
| Year Founded | 2000 |
| Website | http://www.lancesoft.com/ |
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
About Company
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.
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