Sr Quality Engineer - Exempt
Sr Quality Engineer - Exempt
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Job Title: Sr. Quality Engineer
Client: Medical Device Manufacturing Company
Duration: 08 months (extension possible)
Location: Jacksonville FL 32216
Shift: 1st shift Onsite preferred (3 5 days/week); hybrid possible
Job Description:
Seeking experienced Sr. Quality Engineers to support critical medical device projects during employee time off. Focus areas include risk management TMV and validation activities.
Primary Responsibilities
- Support multiple projects with quality and supplier quality functions
- Lead risk reviews and ensure ISO compliance
- Execute and document IQ/OQ/PQ/MVP/TMV
- Maintain Design & Risk Management Files
- Support root cause analysis (5 Whys Ishikawa Pareto)
- Collaborate with R&D Regulatory Manufacturing
- Improve inspection/test methods and quality processes
- Apply statistical tools and SPC
- Drive risk mitigation across lifecycle
Must-Have Qualifications:
Education:
- Bachelors in Engineering (required)
Experience:
- 4 years in medical device industry in Quality Engineering or Supplier Quality
- Or 2 years with an advanced degree
Core Expertise:
- Test Method Validation (TMV)- Must have at least 4 years
- Measurement System Analysis (MSA)- Must have at least 4 years
- Risk files: RPM P1/P2 design files mitigations
- Validation/Qualification: IQ/OQ/PQ sampling MVPR PPAP statistics
- Strong documentation communication and independent work capability
Nice-to-Haves
- ASQ CQE Lean Six Sigma DMAIC
- Bilingual (English/Spanish)
- Prior Medtronic or regulated industry experience
- Manufacturing background
#ZR
Employment Type
Full-time
