ANALYST, QC-Remote

Compass Group•Tredyffrin Township, PA

1d•Remote

About The Position

Intelas, a Compass Healthcare company, is seeking a Quality Control Analyst to support its Quality Management System (QMS) and lead assigned audit and compliance activities across a national healthcare technology program. This role involves translating regulatory and accreditation expectations into controlled processes, objective evidence, corrective actions, and measurable performance, supporting ISO 13485:2016 conformity, applicable CMS requirements, and DNV and Joint Commission accreditation standards. The position is ideal for a detail-oriented quality professional who can interpret requirements, lead evidence-based reviews, communicate risk, and strengthen medical device safety. This is a remote, full-time position that requires national travel.

Requirements

Bachelor’s degree in healthcare technology management, quality management, engineering, or a related field.
Four or more years of experience in healthcare technology management, medical device quality, or quality systems.
Two or more years administering QMS or eQMS databases and quality records.
Working knowledge of ISO 13485:2016, applicable CMS requirements, and DNV and Joint Commission standards.
Ability to interpret standards, audit evidence, and performance data and communicate conclusions clearly.
Strong technical writing, organization, analysis, and record-management skills.
Ability to manage concurrent audits, CAPAs, complaints, alerts, and improvement projects.
Valid driver’s license and ability to travel nationally for on-site internal audits.

Nice To Haves

Internal lead auditor or ISO 13485 auditor certification preferred.
Willingness to complete company-approved lead internal auditor training within the timeframe established at hire if uncertified.

Responsibilities

Lead risk-based internal audits, including planning, evidence review, interviews, reporting, and corrective-action follow-up.
Administer QMS processes, document control, training and quality records, process monitoring, retention, and traceability.
Coordinate containment, root-cause analysis, action plans, effectiveness checks, escalation, and timely closure of CAPAs.
Investigate complaints, document findings, assess escalation needs, and track actions through resolution.
Analyze QMS data, communicate risks and trends, and provide compliance guidance to leaders, field teams, customers, suppliers, vendors, and leadership.