Quality Systems Specialist Remote

Northbound Search; Lehi (UT); Remote; USD 70,000 - 90,000; Full time

Job summary

A leading company is seeking a remote QMS Specialist to drive ISO 13485/FDA readiness and strengthen compliance processes within a regulated environment. The role includes implementing an eQMS, managing quality documents, and coordinating internal audits, with occasional travel to Lehi, Utah. Ideal candidates will have experience in the medical device industry and strong organizational skills.

Qualifications

• 2–5 years of experience in a regulated industry (medical devices, pharmaceuticals, or biotechnology).
• Working knowledge of ISO 13485, 21 CFR Part 820, EU MDR, and ISO 14971.

Responsibilities

• Support implementation and administration of an eQMS platform compliant with 21 CFR Part 11.
• Manage document control workflows and ensure accuracy of controlled documents.
• Coordinate quality events such as CAPAs, deviations, and change requests.

Skills

Attention to Detail

Organizational Skills

Collaboration

Tools

eQMS platforms

Job description

Job Description

Job Description

Position: QMS Specialist - REMOTE

Seeking a QMS Specialist to support Dot Compliance (eQMS) implementation and drive ISO 13485/FDA readiness. This role will help shift the quality culture toward regulated-med device standards. This individual will play a key role in strengthening compliance processes and fostering a culture of quality in a regulated environment.

Primary Responsibilities:

• Support implementation and daily administration of an eQMS platform compliant with 21 CFR Part 11

• Manage document control workflows and ensure accuracy and compliance of controlled documents

• Review and revise operational and cross-functional procedures, including work instructions and job-specific documents

• Coordinate and help resolve quality events such as CAPAs, deviations, and change requests

• Assist with internal audits and inspection readiness for ISO, FDA, and MDSAP assessments

• Monitor quality system indicators and contribute to ongoing process improvements

• Partner with cross-functional teams to ensure effective training and compliance tracking

• Occasional travel to Lehi, Utah as needed (travel expenses covered)

Preferred Qualifications:

• 2–5 years of experience in a regulated industry (medical devices, pharmaceuticals, or biotechnology)

• Working knowledge of ISO 13485, 21 CFR Part 820, EU MDR, and ISO 14971

• Prior experience with eQMS platforms (Dot Compliance or similar)

• Strong attention to detail, organizational skills, and ability to manage multiple priorities in a collaborative setting