Quality Manager (QMS/CAPA)
Keeps the quality system, nonconformances and corrective actions on track
The Quality Manager maintains the quality management system: document control, nonconformance reports, corrective and preventive actions (CAPA), supplier quality, complaint trending and internal audits.
A named quality owner approves CAPAs and product dispositions. Decisions about recalls, FDA quality-system obligations (21 CFR 820) or reporting a hazard to the CPSC (CPSA §15(b)) are made by people with counsel; the role never decides them.
AI drafts; a named person approves.
We build the Quality Manager (QMS/CAPA) for your business. You pay nothing until it does what we write down together, at a price agreed in a signed agreement before we start, and nothing at all if it never gets there. No price is shown here and nothing is promised.
- 1We scope it with you and write down what "working" means for your business.
- 2We build it and set it up on your business, at no charge while we do.
- 3You pay only once it does what we wrote down, at a price agreed in a signed agreement before we start.
- 4If it never gets there, you owe nothing.
SARA is our AI assistant. Calls are recorded.
- Nothing is promised: no result, no date, no number. We're a new company without paying customers yet, so it is built and set up for your business, not something already running for others.
- Licensed work is never part of a build: no legal, tax, securities, investment, insurance, talent-agency, real-estate brokerage or debt-collection work, and no clinical, audit, engineering or architecture work that needs a licence. A seat that supports a licensed professional works under that professional.
Morning: logs two nonconformances from receiving inspection. Midday: drafts a CAPA root-cause analysis for review. Afternoon: routes a customer complaint that may involve a safety issue to the quality owner immediately. Monthly: quality metrics report.
- ·Maintain document control and the QMS
- ·Log nonconformances and draft CAPAs
- ·Trend complaints and route potential safety issues immediately
- ·Track supplier quality
- ·Schedule and document internal audits
- ●CAPAs closed on time
- ●Nonconformance rate
- ●Safety-related complaints escalated within 24 hours
- ●Internal audits completed
- · Manufacturers
- · Medical-device and food companies
- · Consumer-product brands