Keep a quality manager — or the owner wearing that hat — accountable for daily MRB, shipping quality, and the signatures. Bring in Stratos for the specialist load: gap work, NC-CAPA backlog, audit prep, document control, training. We sell capacity and audit readiness, not a staffing firm and not a QMS app.
Quality managers and owners at shops of 15–200 people, with a certification clock or a customer mandate. Not a pitch to skip hiring.
What stays with the people who sign
Daily nonconforming product, shipping quality, customer complaints, walking the floor. That job does not go away if you hire a consultant. We should not sit in your standup every morning, or sign what the quality manager should sign.
Where capacity actually runs out
The pain is rarely another software seat. It is overdue records, an NC-CAPA pile that will not close, an audit, or document control that drifted from the work. We are here for cycle time and audit readiness, not to argue against a hire.
- Process owners who cannot speak to the procedure when the auditor sits down
- NC-CAPA with containment and no root cause, or the same escape twice
- Evidence scattered across shared drives
- Obsolete work instructions still on the floor
Side by side
| Quality manager on the payroll | Outsourced team (Stratos) | |
|---|---|---|
| On the floor daily | Yes. That is the job. | No. We come in for scoped work. |
| AS9100D / ISO depth | Depends on who you can hire. | AS9100D and ISO 13485 lead auditor. ISO 9001 quality-system work. |
| Spiky load (recert, customer finding, QMSR mapping) | Nights and weekends on the same person. | That is the point of hiring the work out. Capacity, not a layoff. |
| Software | Uses your tools. | No portal you log into. |
| Accountability | Signs. Stays the quality system owner. | Does the work, not the regulatory responsibility. |
A clean split
Many plants already have a quality manager and still bring in help for the recert, the CAPA backlog, or procedures the floor will follow. That is not a failure of the hire. It is how a 15–200 person plant covers a standard written for a much larger quality department. Plants that run both ISO 13485 and AS9100D feel this first.
Stratos is a service, not a tool you log into. If this page does not match your contract or your registrar, follow the contract.