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Manager, Quality Engineering

Advitaortho · Gainesville, FL, Gainesville, Florida · On Site · Active · Pinpoint

Job facts

FieldValue
CompanyAdvitaortho
TitleManager, Quality Engineering
Normalized title-
Department / teamQuality
LocationGainesville, FL, United States
Work modelOn Site
Employment typeFull Time
Salary0-0
Statusactive
ATS providerPinpoint
Posted / first seen / 2026-05-31
Changed / last seen2026-05-31 / 2026-06-06

Related slices

PageWhat it containsOpen
Company jobsActive postings from Advitaortho.Open
Company breakdownsRole, location, ATS, and work model facets for this company.Open
ATS provider jobsActive postings observed through Pinpoint.Open
Provider filtered searchThe same provider as a filtered job collection.Open
City jobsActive postings in Gainesville.Open
Department jobsActive postings in Quality.Open
Work model jobsActive On Site postings.Open
Lifecycle eventsOpen, update, close, and reopen events for this posting.Open
Original postingCanonical source or apply URL captured from the ATS.Open

Linked records

CompanyAdvitaortho
Source28fc7f4c-baf7-4fc4-96e9-8eb2f8cae015
ATS providerPinpoint

Description

The Manager, Quality Engineering, provides leadership to the Quality Engineering team by inspiring individuals and teams while creating an environment of organizational excellence to deliver results. Quality & Regulatory Compliance: Ensure alignment with FDA, ISO 13485, MDSAP, EU MDR, and internal QMS; maintain audit readiness and certification compliance. Quality Engineering Leadership: Lead and develop the Quality Engineering team; align goals, performance, and resources to business objectives. Product Realization (Design & Manufacturing): Oversee design controls, risk management, verification/validation, and process validation; ensure compliance with GD&T, inspection, and statistical requirements. CAPA & Investigations: Drive root cause analysis, corrective/preventive actions, and cross-functional resolution of quality issues. Complaints & Nonconformance: Lead investigation, containment, disposition, and timely resolution of complaints and nonconforming product; escalate risks as needed. Data & Reporting: Track, analyze, and report quality metrics; support Management Review and Quality Governance. Audit Support: Serve as SME during internal and external audits/inspections. Education: Bachelor’s Degree in Science from an accredited institution required; Master’s Degree preferred Experience: Minimum of 7 years experience, preferably in orthopedic or other medical device field. Working understanding and leadership capability to ensure Quality System requirements are implemented and measured for effectiveness. Minimum of 0-5 years prior QA Engineering management experience in a Medical Device Company. Experience in inspection specification development, statistical techniques, gage R&R, and G,D&T applications Prior audit experience with FDA and notified bodies. Functional/Technical Knowledge, Skills and Abilities Required: Excellent verbal, written communication and leadership skills. Ability to work with all organizational functions.

Full job record

Job ID9fe2c1020c6f790963f242f82f798ef9a06e4737
Org IDa9472c2d-74d0-4937-ac23-1f32eca977b6
Source ID28fc7f4c-baf7-4fc4-96e9-8eb2f8cae015
Board ID28fc7f4c-baf7-4fc4-96e9-8eb2f8cae015
Providerpinpoint
Provider Job Key492855
TitleManager, Quality Engineering
Normalized Title
Statusactive
Activeyes
Location TextGainesville, FL, Gainesville, Florida
DepartmentQuality
Team
Employment Typefull_time
Workplace Typeon_site
Remote Policy
CountryUnited States
RegionFL
CityGainesville
Salary Raw0-0
Salary Min0
Salary Max0
Salary Currency
Salary Period
Source URLhttps://advitaortho.pinpointhq.com/en/postings/2b3e23b9-0350-473a-93ee-fbb59378e817
Apply URLhttps://advitaortho.pinpointhq.com/en/postings/2b3e23b9-0350-473a-93ee-fbb59378e817
First Seen At2026-05-31 17:45:32Z
Last Seen At2026-06-06 19:39:43Z
Last Checked At2026-06-06 19:39:43Z
Last Changed At2026-05-31 17:45:32Z
Inactive At
Source Posted At
Source Updated At
Raw Payload Uris3://job-postings-prod-raw-590183727216/raw/provider=pinpoint/board=advitaortho/date=2026-06-06/2026-06-06T19-39-42-458Z-6e15d5451eccfd00f4c67152c4cd47b429217ccc2d2db02bc11bb63c86d9b4f4.json
Event Fields
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  "last_changed_at": "2026-05-31T17:45:32.967Z",
  "active_status": "active"
}
Parsed Structured
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    "region": "FL",
    "country": "United States",
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}
Extensions
{}
Native Structured
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  "url": "https://advitaortho.pinpointhq.com/en/postings/2b3e23b9-0350-473a-93ee-fbb59378e817",
  "path": "/en/postings/2b3e23b9-0350-473a-93ee-fbb59378e817",
  "title": "Manager, Quality Engineering",
  "benefits": "",
  "location": {
    "id": "5732",
    "city": "Gainesville",
    "name": "Gainesville, FL",
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  },
  "deadline_at": null,
  "description": "<div><!--block-->&nbsp;The Manager, Quality Engineering, provides leadership to the Quality Engineering team by inspiring individuals and teams while creating an environment of organizational excellence to deliver results.&nbsp;</div>",
  "compensation": null,
  "reporting_to": "Director, Quality Management Systems",
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  "key_responsibilities": "<ul><li><!--block--><strong>Quality &amp; Regulatory Compliance:</strong> Ensure alignment with FDA, ISO 13485, MDSAP, EU MDR, and internal QMS; maintain audit readiness and certification compliance.</li><li><!--block--><strong>Quality Engineering Leadership:</strong> Lead and develop the Quality Engineering team; align goals, performance, and resources to business objectives.</li><li><!--block--><strong>Product Realization (Design &amp; Manufacturing):</strong> Oversee design controls, risk management, verification/validation, and process validation; ensure compliance with GD&amp;T, inspection, and statistical requirements.</li><li><!--block--><strong>CAPA &amp; Investigations:</strong> Drive root cause analysis, corrective/preventive actions, and cross-functional resolution of quality issues.</li><li><!--block--><strong>Complaints &amp; Nonconformance:</strong> Lead investigation, containment, disposition, and timely resolution of complaints and nonconforming product; escalate risks as needed.</li><li><!--block--><strong>Data &amp; Reporting:</strong> Track, analyze, and report quality metrics; support Management Review and Quality Governance.</li><li><!--block--><strong>Audit Support:</strong> Serve as SME during internal and external audits/inspections.</li></ul><div><!--block--><br></div>",
  "compensation_currency": null,
  "compensation_frequency": null,
  "skills_knowledge_expertise": "<div><!--block--><strong>Education:</strong></div><ul><li><!--block-->Bachelor’s Degree in Science from an accredited institution required; Master’s Degree preferred</li></ul><div><!--block--><strong>&nbsp;Experience:</strong></div><ul><li><!--block-->Minimum of 7 years experience, preferably in orthopedic or other medical device field.&nbsp;</li><li><!--block-->Working understanding and leadership capability to ensure Quality System requirements are implemented and measured for effectiveness.&nbsp;</li><li><!--block-->Minimum of 0-5 years prior QA Engineering management experience in a Medical Device Company.&nbsp;</li><li><!--block-->Experience in inspection specification development, statistical techniques, gage R&amp;R, and G,D&amp;T applications</li><li><!--block-->Prior audit experience with FDA and notified bodies.</li></ul><div><!--block--><strong>Functional/Technical Knowledge, Skills and Abilities Required:</strong></div><ul><li><!--block-->Excellent verbal, written communication and leadership skills.</li><li><!--block-->Ability to work with all organizational functions.</li></ul><div><!--block--><br></div>",
  "key_responsibilities_header": "Key Responsibilities",
  "skills_knowledge_expertise_header": "Skills Knowledge and Expertise"
}
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