2mo
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Senior Operations Engineer
Alachua, Florida, United States
$85k-$100k/yr OnsiteFull Time
6+ YOE6+ years engineering in designing/modifying processes and equipment; ISO 13485 experience; Class III device experience; bachelor's in engineering preferred.
Microsoft Office Suite, Advanced Excel, CAD (Computer Aided Drafting), Project management, Communication tools, Statistical analysis, Lean manufacturing
2mo
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Sr. Quality Engineer
Alachua, Florida, United States
$90k-$115k/yr OnsiteFull Time
6+ YOEBachelor’s degree in a relevant technical discipline; 6+ years in regulated medical device/pharmaceutical industry; certifications preferred; strong communication, problem solving, MS Office, and QMS software experience.
Microsoft Office, Quality Management System software, Statistical techniques, Investigations
2w
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Sr. Supply Quality Engineer
Gainesville, Florida, United States
OnsiteFull Time
5+ YOE5+ years supplier quality experience in medical device or regulated industry; knowledge of ISO 13485, 21 CFR Part 820, GD&T, SPC; ISO 13485 Lead Auditor certification required or to be completed within a year; bachelor’s degree required.
2w
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Sr. Supply Quality Engineer
Gainesville, Florida, United States
OnsiteFull Time
5+ YOEBachelor's degree required (Master's preferred), 5+ years supplier quality experience in medical device or regulated industry, ISO 13485 lead auditor certification (or obtain within a year), knowledge of ISO 13485/14971/17025 and 21 CFR Part 820, GD&T, IQ/OQ/PQ, SPC, and supplier auditing with ~25% travel.
3mo
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Sr. R&D Project Manager
Alachua, Florida, United States
$100k-$125k/yr OnsiteFull Time
6+ YOEBachelor's degree in engineering or related field; 6+ years PM in medical devices; PMP preferred; strong communication; CAD, MS Office; travel not indicated.
CAD, Microsoft Office, Project Management software, Statistical analysis software
1mo
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Sr. Cost Optimization Project Manager
Gainesville, Florida, United States
OnsiteFull Time
6+ YOEBachelor's in engineering/operations/supply chain required; 6+ years in medical device or regulated manufacturing; 2+ years leading cross-functional programs; proven cost reduction, value engineering, and regulatory (ISO/FDA/Design Controls) experience.
Lean, Six Sigma, Value Engineering, Design-to-Cost, Design Controls, Quality Management System (QMS), ISO, FDA
1mo
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Sr. Cost Optimization Project Manager
Gainesville, Florida, United States
OnsiteFull Time
6+ YOEBachelor's in engineering/operations/supply chain, 6+ years in medical device or regulated manufacturing, 2+ years leading cross-functional programs, experience driving cost-out/value engineering, knowledge of Design Controls, QMS, ISO, and FDA requirements.
Design Controls, Quality Management System (QMS), Lean, Six Sigma, ISO standards, FDA regulations, BOM