Sr Quality Engineer - Exempt

Job DescriptionJob Descriptionn

Job Title: Sr. Quality Engineer

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Client: Medical Device Manufacturing Company

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Duration: 08 months (extension possible)

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Location: Jacksonville, FL, 32216

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Shift: 1st shift, Onsite (3–5 days/week); hybrid possible

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Job Description:

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Seeking experienced Sr. Quality Engineers to support critical medical device projects during employee time off. Focus areas include risk management , TMV , and validation activities .

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Primary Responsibilities

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• Support multiple projects with quality and supplier quality functions
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• Lead risk reviews and ensure ISO compliance
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• Execute and document IQ/OQ/PQ/MVP/TMV
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• Maintain Design & Risk Management Files
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• Support root cause analysis (5 Whys, Ishikawa, Pareto)
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• Collaborate with R&D, Regulatory, Manufacturing
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• Improve inspection/test methods and quality processes
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• Apply statistical tools and SPC
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• Drive risk mitigation across lifecycle
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Must-Have Qualifications:

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Education:

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• Bachelor’s in Engineering (required)
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Experience:

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• 4+ years in medical device industry in Quality , Engineering , or Supplier Quality
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• Or 2+ years with an advanced degree
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Core Expertise:

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• Test Method Validation (TMV)- Must have at least 4 years
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• Measurement System Analysis (MSA)- Must have at least 4 years
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• Risk files : RPM P1/P2, design files, mitigations
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• Validation/Qualification : IQ/OQ/PQ, sampling, MVPR, PPAP, statistics
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• Strong documentation , communication , and independent work capability
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Nice-to-Haves

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• ASQ CQE , Lean Six Sigma , DMAIC
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• Bilingual (English/Spanish)
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• Prior Medtronic or regulated industry experience
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• Manufacturing background
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Company DescriptionAs a leading contract, contract-to-hire and professional placement firm, Three Point Solution understands the importance of aligning our client with the right resource at the right time. We are committed to the highest caliber of service that will benefit our clients, candidates and employees. Unlike large, corporate style recruiting firms, we commit to individualized attention that uniquely positions us to bridge the communication gap between recruiter, employer and candidate. Our goal is to cultivate and maintain true partnerships with our clients and candidates.Company DescriptionAs a leading contract, contract-to-hire and professional placement firm, Three Point Solution understands the importance of aligning our client with the right resource at the right time. We are committed to the highest caliber of service that will benefit our clients, candidates and employees. Unlike large, corporate style recruiting firms, we commit to individualized attention that uniquely positions us to bridge the communication gap between recruiter, employer and candidate. Our goal is to cultivate and maintain true partnerships with our clients and candidates.