Quality & Process Improvement Specialist

Quality & Process Improvement Specialist

Finance & Operations Team - Full-Time

On-Site in Boise, Idaho

The Challenge:
Saalt makes reusable period care products, including FDA-registered medical devices, some of which are packaged and labeled in our Boise facility. We’re looking for a process-minded quality professional to own our Quality Management System and make our operations faster, leaner, and more reliable. You’ll be supported by an AI-powered QMS assistant that handles scheduling, form prep, revision tracking, and compliance reminders, plus a part-time regulatory consultant for audits and interpretation.

That frees you to spend your time on what matters: optimizing the quality system to improve how we work, and predictably and efficiently deliver safe products to our customers while keeping the system and processes documented and compliant as we grow.

This role is a fit for someone who improves things by building better systems—and who finishes what they start. You’ll find the waste, fix it, and make sure the fix is written down, trained, and sticks.

• Own the QMS: Maintain our ISO 13485–aligned Quality Management System, including document control, change control, CAPAs, complaint handling, training records, and internal audits. Keep every record current and audit-ready.
• Drive process improvement: Map warehouse, packaging, labeling, kitting, and fulfillment processes; identify waste; and implement measurable improvements in cycle time, error rates, and cost.
• Build standard work: Turn improvements into clear SOPs, work instructions, and visual aids the team actually follows—routed through change control.
• Partner with AI: Work alongside our AI QMS assistant to keep compliance calendars, forms, revisions, and approvals current. Help us improve the system as we build it.
• Supplier quality: Run supplier gap analyses and monthly top-of-production (TOP) audits to verify
• quality standards and vendor compliance.
• Safety: Support OSHA compliance and safety processes for our warehouse.
• Management review: Compile data, metrics, and documentation for Quality Management Reviews.
• Audit readiness: Partner with our regulatory consultant and leadership on FDA inspections, external audits, and escalated regulatory questions.

• 3–5 years of experience in process improvement, manufacturing operations, or quality, including at least 2 years 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).
• A strong preference for structure, follow-through, and accurate documentation—you love finding a better way and writing it down so it sticks.
• Comfortable with data (Excel/Google Sheets; Minitab or similar a plus) and with AI tools.
• Clear written and verbal communication; works well independently and across teams.
• Bachelor’s degree in engineering, operations, or a related field preferred, or equivalent work
• experience.
• Able to lift and carry 50 lbs.

• ISO 13485 or 21 CFR 820 (QMSR) experience.
• Internal auditor training or certification.
• Experience with packaging, labeling, or kitting operations.

• $65,000–$72,000 annual salary, commensurate with experience

• Company Paid Health Insurance (medical/dental/vision/life)
• 401(k) & Roth 401(k)
• No-Cost, In-House Preschool
• Casual Dress Code
• Flexible PTO

Saalt empowers people to care for their periods in a healthy and sustainable way. We do this by creating high-performance products and stigma-breaking branding that engage customers and communities,…