Minimum Viable QMS
Review and finalize executable procedures and records for supplier qualification and change, SKU lock, receiving, release, traceability, lot/expiry, NCR, complaints, returns, recalls and CAPA-lite.
ZERTELA Careers · Professional opportunity
Fractional Quality & Regulatory Lead
Costa Rica | Hybrid / Primarily Remote
Fractional / outsourced professional-services engagement.This is not a full-time or part-time employee position.
Help build the Minimum Viable Quality & Regulatory foundation for a pre-revenue Supply Assurance model serving Costa Rica's MedTech and Life Sciences ecosystem.
About the engagement
Build the right foundation—without premature complexity.
ZERTELA is preparing a controlled pilot for selected materials and consumables used in regulated manufacturing. We need independent senior Quality & Regulatory judgment to validate a lean, executable system, close material gaps and support real supplier, SKU, import and customer evidence as it becomes available.
What you will do
Translate regulated requirements into practical operating controls.
Regulatory applicability
Create and apply a decision framework for Costa Rica MINSA, Regístrelo, permits, registration and regency triggers by activity and product category.
Supplier-quality evidence
Define the minimum evidence pack and qualification scorecard across specifications, certificates, CoA/CoC/SDS, manufacturing site and origin, change notification, gaps and escalation.
QA / import / 3PL interface
Establish a practical broker, 3PL and warehouse interface for hold/release, receiving documentation, traceability and disposition.
Technical customer support
Prepare and attend selected customer VOC or technical meetings in Costa Rica, capture Quality & Regulatory requirements and translate them into actions.
Pilot and exception support
Review selected shipment, release, deviation, complaint, documentation or material-change events under a pre-agreed scope.
Ideal background
Senior hands-on expertise in regulated supply environments.
This engagement suits an experienced independent professional who can be pragmatic without weakening compliance discipline.
What matters most
- Relevant QA/QMS and Regulatory experience in MedTech or highly regulated Life Sciences.
- Practical knowledge of ISO 13485; ISO 9001 experience is also valuable.
- Hands-on supplier qualification, supplier change control, CAPA/NCR and complaint/return/recall processes.
- Understanding of receiving, release, traceability and lot/expiry controls across imported products and 3PL operations.
- Familiarity with Costa Rica MINSA and Regístrelo requirements and the ability to distinguish applicability, evidence and formal execution.
- Professional English for supplier documentation and technical conversations.
- Costa Rica-based, ideally in GAM, and able to attend selected in-person meetings.
Engagement model
Capacity follows the evidence and the phase.
Setup · Sep–Oct 2026
10–14 hours total
Concentrated MVP setup and capability transfer.Post-setup
0–1 hour / week
Review only while no real SKU is active.Nov–Dec 2026
2–3 hours / week + F2F
Candidate SKU, supplier-quality and selected VOC work.JFM 2027
1–2 hours / week + event-driven
Pilot execution, exceptions and material events.Selected in-person meetings: planning assumption of 2–4 hours each, including preparation and reasonable local travel, always agreed in advance.
Formal regency, registrations, renewals, fees, audits, extraordinary travel and material crises are outside the base scope unless separately agreed.
What success looks like
A minimum system that is usable, evidence-based and ready for a controlled pilot.
- 01
Editable, executable procedures, templates, checklists and decision records are in place.
- 02
Material regulatory questions are CLOSED or clearly CONDITIONAL on sufficient SKU data.
- 03
An end-to-end dry run—from supplier qualification and SKU lock through import, release, traceability and complaint/recall—has no critical gap without an owner and date.
- 04
Real supplier, SKU, customer and shipment evidence can be reviewed efficiently as the pilot advances.
Application process
A focused review for a focused engagement.
Submit interest
Share only the information requested below and attach your CV or résumé.
Fit review
ZERTELA reviews relevant technical experience, fractional availability and commercial fit.
Selected conversation
Shortlisted candidates are invited to a focused technical and engagement discussion.
Apply / Submit interest
Tell us about your fit for this engagement.
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