Head of Quality Assurance

15 hours ago

Charlotte, North Carolina, United States PeakVisibility Partners LLC Full time $140,000 - $192,000 per year

About the engagementConsulting prime supporting a medical-device shop. Execute the approved proposal & SOW on a fast, tightly scoped 6–10 week timeline. You'll own the QMS and act as ISO 13485 Management Representative. Reports to the consulting Program Lead (who interfaces with client executives).Scope & ownership• Rapid gap → plan → implement against SOW• Plan/host NB/MDSAP/customer/supplier audits (as applicable)• Design Controls, DHF/DMR, doc control, training cadence, KPIs• CAPA/NCR/SCAR: triage, 8D/5-Why, effectiveness checks• ISO 14971 risk files: create/repair & link to design/ops• Supplier quality: approve/qualify/audit; PPAP/FAI if needed• FDA QMSR/21 CFR 820 alignment; EU MDR awareness• Change control, calibration, IQ/OQ/PQ, internal audits• Authority to stop the line; coach on-site quality staffSprint milestones(target)• Week 1: Full gap assessment, risk register, doc map, CAPA inventory, training matrix; sprint board live• Weeks 2–3: High-risk procedures implemented; CAPA backlog running; supplier approvals kicked off• Weeks 4–5: Validation plan, DMR/DHR remediation, ≥80% priority training complete, metrics reporting live• Weeks 6–8: Internal audits executed; Management Review completed; pre-assessment readiness• Weeks 8–10: Close findings; verify effectiveness; handoff package (QMS index, trackers, training, open actions)Must-haves• 5+ yrs med-device with ISO 13485 ownership• 2+ cert/recert audits led as MR/site lead• ISO 13485 Lead Auditor; strong ISO 14971• Proven QMS build/remediation with measurable resultsNice to haveMDSAP; EU MDR/IVDR; DHF remediation; Six Sigma GB/BB; CQE/CQA; eQMS (Greenlight Guru/MasterControl).Success criteria (by sprint end)• High-risk gaps closed per SOW; audit-ready core QMS• ≤10% CAPA past due; >90% priority training on time• Internal audit completion & MR on record; RFT doc change rate >98%• Supplier approvals for critical parts complete/in-flight with dates• Delivered handoff with owners, dates, and open-items trackerContract terms• 1099; scope/hours/deliverables per SOW; start within 5 days• On-site with some travel; reimbursed per SOW• No employer benefits; NDA & onboarding requiredPay Range: $140/hr - $160/hrApplySend resume + a 2-week action plan to stabilize a shop QMS, and a one-pager showing a QMS you built/remediated with before/after metrics.

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