Quality & Process Improvement Specialist

Saalt•Boise, ID

1d•$65,000 - $72,000•Onsite

About The Position

Saalt is seeking a process-minded quality professional to manage their Quality Management System (QMS) and enhance operational efficiency. This role involves making operations faster, leaner, and more reliable, with support from an AI-powered QMS assistant and a part-time regulatory consultant. The specialist will focus on optimizing the quality system, improving work processes, and ensuring predictable and efficient delivery of safe products while maintaining documentation and compliance as the company grows. This position is ideal for someone who excels at building better systems, identifying and fixing inefficiencies, and ensuring improvements are documented, trained, and sustained.

Requirements

3–5 years of experience in process improvement, manufacturing operations, or quality.
At least 2 years of experience in a regulated environment (medical device, pharma, FDA food, aerospace, automotive, or similar).
Lean and/or Six Sigma training (Yellow or Green Belt preferred).
Hands-on experience with CAPA, document control, change control, or internal audits.
Ability to read, interpret, and apply regulations and standards (CFR, ISO, or similar).
Strong preference for structure, follow-through, and accurate documentation.
Comfortable with data (Excel/Google Sheets; Minitab or similar a plus) and with AI tools.
Clear written and verbal communication skills.
Ability to work well independently and across teams.
Able to lift and carry 50 lbs.

Nice To Haves

ISO 13485 or 21 CFR 820 (QMSR) experience.
Internal auditor training or certification.
Experience with packaging, labeling, or kitting operations.
Bachelor’s degree in engineering, operations, or a related field, or equivalent work experience.

Responsibilities

Maintain the ISO 13485-aligned Quality Management System, including document control, change control, CAPAs, complaint handling, training records, and internal audits.
Ensure all records are current and audit-ready.
Map warehouse, packaging, labeling, kitting, and fulfillment processes to identify waste and implement measurable improvements in cycle time, error rates, and cost.
Develop clear SOPs, work instructions, and visual aids based on improvements, ensuring they are routed through change control.
Collaborate with the AI QMS assistant to manage compliance calendars, forms, revisions, and approvals, and contribute to system improvements.
Conduct supplier gap analyses and monthly top-of-production (TOP) audits to verify quality standards and vendor compliance.
Support OSHA compliance and safety processes for the warehouse.
Compile data, metrics, and documentation for Quality Management Reviews.
Partner with the regulatory consultant and leadership on FDA inspections, external audits, and escalated regulatory questions.