Confidential mandate
Board Quality Adviser — Medical Devices
Planned Hiring / New
A medical-device manufacturer seeks independent board challenge on design quality, supplier controls and post-market signals as it expands into higher-risk connected products in export markets.
The mandate
The committee's persistent concern is whether quality governance has evolved quickly enough for software-enabled, remotely monitored devices. Traditional release controls do not give directors a consolidated view of usability, cyber, complaint and supplier signals.
Two days monthly cover a risk-signal review and committee attendance. A credible safety escalation receives acknowledgement within six hours and availability for committee consultation within twenty-four.
The ten-month term reaches through the next management review and portfolio reauthorisation. The committee chair may extend it for two months; the adviser has no line authority, release signature, regulatory-accountable role or executive responsibility.
No more than three concurrent commitments are acceptable. Roles with competing manufacturers, notified assessors, contract manufacturers, software providers or distributors must be disclosed, and paid product endorsement is barred.
Why the board wants this voice
Quality reporting treats design, field service and cyber events in separate streams. Directors want a former quality leader who can connect weak signals before they become patient harm or recall. The adviser supplies independent pattern recognition, not operational certification.
What you will own
- Test whether design-risk files reflect observed use, connectivity and service conditions.
- Challenge complaint closure where coding obscures repeat or cross-product patterns.
- Press the committee on supplier changes that alter validated performance.
- Shape escalation thresholds combining vigilance, cybersecurity and usability evidence.
- Examine whether corrective actions prove effectiveness beyond document closure.
- Guide questions around software updates, remote monitoring and installed-base traceability.
- Advise when a signal warrants restricted release, field action or independent investigation.
Candidate qualifications
- 22–28 years in medical-device quality, regulatory or product-safety leadership.
- Direct accountability for design controls and post-market surveillance on higher-risk devices.
- Experience governing software, cybersecurity or connected-device change.
- Evidence of identifying a safety pattern before formal thresholds were breached.
- Board-committee fluency on field action, supplier and product-risk trade-offs.
- Independence from suppliers and assessors supporting the current portfolio.
Non-negotiables
- Six-hour acknowledgement and twenty-four-hour availability for a credible safety escalation.
- Two Chennai days monthly through portfolio reauthorisation.
- Disclosure of manufacturer, supplier, assessor and distributor relationships.
- No release, regulatory signature or operational quality authority.
- 49 words maximum. Which medical-device signal did you escalate before it became obvious, and what evidence connected the pattern?
- 49 words maximum. What manufacturer, assessor, supplier or distributor relationships could compromise independence?
- 49 words maximum. Can you meet the safety-response cadence while committing two Chennai days monthly?
This mandate is confidential. The client is named only under a mutual NDA, and your own record is never listed, sold or shown to a company under your name until you release it for this specific mandate.