Quality Management Systems Specialist

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the complete lifecycle for corrective and preventive actions (CAPA) and nonconformance reports (NCR) within Qualio.

• Facilitate the CAPA/NCR queue during weekly team meetings, providing updates on status, risks, and obstacles.

• Collaborate with Engineering and various departments to implement remediation actions.

• Manage the entire document control lifecycle in Qualio.

• Take ownership of change events from initiation to closure, ensuring regulatory traceability.

• Draft, revise, and maintain standard operating procedures (SOPs), work instructions, and policies in compliance with ISO 13485, FDA 21 CFR Part 820, and MDSAP.

• Act as the Quality representative in software release processes and engage in release go/no-go assessments.

• Maintain documentation packages for releases, which include change events, updates to the risk register, usability file modifications, design history file entries, and necessary regulatory notifications.

• Coordinate with Engineering, Regulatory, and Clinical Affairs regarding quality-relevant release modifications.

• Enhance and sustain the release sign-off workflow within Qualio.

• Organize and assist with internal QMS audits while tracking corrective actions.

• Serve as the primary QMS contact during third-party and certification body audits.

• Keep abreast of changes in the regulatory landscape that affect QMS compliance.

• Manage the compliance posture related to complaint handling and maintain associated SOPs and work instructions.

• Monitor complaint handling activities, escalating trends, documentation deficiencies, or systemic issues.

• Provide guidance on complaint classification policies and drive resolutions to completion.

• Coordinate periodic reviews of complaint data for CAPA and post-market surveillance signals.

• Manage the Qualio training module and monitor completion rates.

• Lead company-wide QMS training initiatives and develop Loom walkthroughs and guidance materials.

• Assess and support the onboarding of new QMS platform features.

⛳️ Requirements

• 3–5 years of experience in Quality Management Systems (QMS) within a regulated medical device or Software as a Medical Device (SaMD) environment.

• Practical knowledge of ISO 13485, FDA 21 CFR Part 820, and MDSAP.

• Experience with EU MDR and/or Health Canada regulatory requirements is advantageous.

• Direct experience in managing CAPAs, NCRs, and change events using a QMS platform.

• Familiarity with Qualio is highly preferred.

• Experience in participating in software release processes from a Quality perspective.

• Ability to connect software modifications to QMS documentation requirements.

• Capability to manage a live compliance queue with multiple items while providing leadership visibility in weekly reviews.

• Excellent written communication skills.

• Highly organized, detail-oriented, and adept at managing several concurrent tasks without missing deadlines or documentation.

• Collaborative approach with a low-ego attitude.

• Experience in supporting MDSAP renewal audits and addressing certification body findings is a plus.

• Familiarity with SaMD-specific quality considerations, such as software validation, algorithm change protocols, and IEC 62304, is a plus.

• Experience in evaluating or implementing next-generation QMS platforms is a plus.

• Background in post-market surveillance and complaint trend analysis for AI-driven medical devices is a plus.

🏝️ Benefits

• Competitive benefits and compensation packages.

• Continuous training and development opportunities.

• Flexible, unaccrued Paid Time Off (PTO).

• Option for remote work.