Medical Device Quality Remediation Director — Consulting

The mandate

The defined problem is a quality-system gap across design change, software release, complaints and supplier correction for one connected-device family. Procedures exist, but objective evidence does not prove consistent execution or effective closure.

The deliverable is a confirmed gap baseline, risk-ranked remediation plan, reconstructed traceability where supportable, revised controls, effectiveness tests, trained owners and an inspection-ready evidence dossier.

Milestone one lands 31 October 2026 with gap and product-risk assessment; milestone two on 15 January 2027 with implemented controls and remediated priority records; milestone three on 31 March with effectiveness evidence and mock-inspection closure.

The Oversight Committee accepts when all critical gaps close with approved evidence, sampled records meet traceability criteria, two effectiveness cycles pass, independent mock inspection reports no major finding and the Chief Quality Officer signs sustainability.

The client provides complete quality records, source and release history, complaints, supplier files, subject experts and document control. Management retains regulatory reporting and product-disposition authority.

Why this is external work

The quality organisation must continue release and surveillance while remediating historical evidence. Independent specialists add capacity and challenge without marking their own prior work. A fixed exit after effectiveness testing prevents permanent dependence.

What you will own

• Confirm the milestone-one gap baseline against product and patient risk.
• Link design, software, supplier, complaint and CAPA evidence by requirement.
• Prioritise remediation where records can be reconstructed credibly.
• Redesign controls with named execution and review ownership.
• Test revised controls across two live effectiveness cycles.
• Conduct a mock inspection and close resulting gaps.
• Transfer the milestone-three dossier, training and sustainability measures.

Candidate qualifications

• 22–28 years in medical-device quality, regulatory or remediation leadership.
• Direct recovery of a quality system with connected-device or software evidence gaps.
• Experience linking design controls, complaints, suppliers and CAPA.
• Evidence of passing effectiveness tests and independent mock inspection.
• Strong judgement on credible reconstruction versus unsupported backfilling.
• Ability to work without assuming regulatory-signatory authority.

Non-negotiables

• No fabrication or retrospective creation of unsupported evidence.
• Full-time onsite leadership during remediation and mock inspection.
• Client Chief Quality Officer retains all regulatory and release authority.
• Final fee is not contingent on an inspection outcome.

1. 49 words maximum. Which medical-device remediation did you lead, and what evidence could not ethically be reconstructed?
2. 49 words maximum. How would you test effectiveness across design, complaint and supplier controls?
3. 49 words maximum. Which records and product experts must be available during the first month?