Quality & Process Improvement Specialist

Saalt•Boise, ID

7d•Onsite

About The Position

Saalt is seeking a process-minded quality professional to join their Finance & Operations Team in Boise, Idaho. This full-time, on-site role focuses on owning the Quality Management System (QMS) to make operations faster, leaner, and more reliable. The specialist will be supported by an AI-powered QMS assistant and a part-time regulatory consultant, allowing them to concentrate on optimizing the quality system, improving operational efficiency, and ensuring product safety and compliance. The ideal candidate is someone who excels at identifying and implementing systemic improvements and ensuring these changes are documented 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 standard work documentation, including SOPs, work instructions, and visual aids, ensuring they are routed through change control.
Collaborate with the AI QMS assistant to manage compliance calendars, forms, revisions, and approvals.
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.