Quality Management Systems Specialist

Pearl

. Own the end-to-end lifecycle for corrective and preventive actions and nonconformance reports in Qualio .

Posted 9/23/2026full-timeRemote • United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing the end-to-end lifecycle of corrective and preventive actions (CAPA) and nonconformance reports (NCR) within a Quality Management System (QMS), with a strong focus on regulatory compliance and documentation management. Proficient in collaborating across departments to ensure quality standards are met in software release processes and maintaining compliance with ISO 13485 and FDA regulations.

Highest-signal resume keywords

QMS ExperienceISO 13485 FamiliarityCAPA ManagementQualio ExperienceRegulatory Compliance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

CAPA ManagementNCR ManagementChange Event ManagementDocument ControlSOP DraftingRegulatory TraceabilitySoftware Release ProcessesPost-Market SurveillanceComplaint HandlingQuality Audits

Soft Skills

Strong Written CommunicationOrganizedDetail-OrientedCollaborativeAbility to Manage Multiple Tasks

Tools & Technologies

QualioQMS Platforms

Industry Keywords

FDA 21 CFR Part 820MDSAPEU MDRSaMDIEC 62304

About the role

Key responsibilities & impact

Own the end-to-end lifecycle for corrective and preventive actions and nonconformance reports in Qualio
Run the CAPA/NCR queue in weekly team meetings and report status, risks, and blockers
Partner with Engineering and other departments on remediation actions
Manage the full document control lifecycle in Qualio
Own change events from initiation through closure and ensure regulatory traceability
Draft, update, and maintain SOPs, work instructions, and policies aligned with ISO 13485, FDA 21 CFR Part 820, and MDSAP
Serve as Quality representative in software release processes and participate in release go/no-go reviews
Maintain release documentation packages, including change events, risk register updates, usability file updates, design history file entries, and required regulatory notifications
Coordinate with Engineering, Regulatory, and Clinical Affairs on quality-relevant release changes
Maintain and improve the release sign-off workflow in Qualio
Coordinate and support internal QMS audits and track corrective actions
Serve as primary QMS contact for third-party and certification body audits
Monitor regulatory landscape changes affecting QMS compliance
Own complaint handling compliance posture and maintain related SOPs and work instructions
Monitor complaint handling activity and escalate trends, documentation gaps, or systemic issues
Provide policy guidance on complaint classification and drive decisions to closure
Coordinate periodic complaint data reviews for CAPA and post-market surveillance signals
Administer the Qualio training module and track completion rates
Drive companywide QMS training campaigns and create Loom walkthroughs and guidance materials
Evaluate and support onboarding of new QMS platform capabilities

Requirements

What you’ll need

3–5 years of QMS experience in a regulated medical device or SaMD environment
Hands-on familiarity with ISO 13485, FDA 21 CFR Part 820, and MDSAP
Experience with EU MDR and/or Health Canada regulatory requirements is a plus
Direct experience managing CAPAs, NCRs, and change events in a QMS platform
Qualio experience strongly preferred
Experience participating in software release processes in a Quality capacity
Ability to connect software changes to QMS documentation requirements
Ability to own a live, multi-item compliance queue and maintain visibility for leadership in weekly reviews
Strong written communication skills
Organized, detail-oriented, and able to manage multiple in-flight items without missing deadlines or documentation
Collaborative and low-ego
Experience supporting MDSAP renewal audits and responding to certification body findings is nice to have
Familiarity with SaMD-specific quality considerations, including software validation, algorithm change protocols, and IEC 62304, is nice to have
Experience evaluating or implementing next-generation QMS platforms is nice to have
Background in post-market surveillance and complaint trend analysis for AI-powered medical devices is nice to have

Benefits

Comp & perks

Competitive benefit and compensation offerings
Ongoing training and development opportunities
Unaccrued, flexible PTO
Remote work