Quality Associate

Podimetrics

Quality Associate supporting medical-device complaint handling, surveillance, document control, QMS, and audits at Podimetrics. Monitoring patient devices and maintaining FDA- and ISO-compliant quality operations.

Posted 8/11/2026full-timeRemote • 🇺🇸 United StatesJuniorMid-Level💰 $65,000 - $85,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Management Systems (QMS) and regulatory compliance, particularly with FDA 21 CFR 820 and ISO 13485. Proficient in complaint handling, document control, and supporting internal audits and CAPA processes.

Highest-signal resume keywords

Quality Management Systems (QMS)FDA 21 CFR 820 ComplianceISO 13485 FamiliarityComplaint Handling ExperienceDocument Control Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Management Systems (QMS)Complaint HandlingDocument ControlCAPA DocumentationData AnalysisRegulatory Audits SupportMicrosoft Office Suite ProficiencyEQMS Software ExperienceInternal Audits SupportTraining Management

Soft Skills

Analytical ThinkingProblem-SolvingExcellent Organizational SkillsStrong Collaboration SkillsExcellent Communication Skills

Tools & Technologies

QMS SoftwareDocument Control SystemsData Trend Monitoring Tools

Industry Keywords

Medical Device IndustryPost-Market SurveillanceDevice Performance MonitoringRegulatory ComplianceQuality System Audits

About the role

Key responsibilities & impact

Review incoming patient feedback daily and determine whether it meets FDA and ISO 13485 criteria for a formal complaint.
Initiate complaint records and conduct initial investigations within the quality system.
Support post-market surveillance by trending device issue data and monitoring recurring or emerging performance issues.
Remotely monitor field devices to identify potential issues and initiate timely device replacements.
Coordinate with Device Operations, Sustaining Engineering, and Clinical Support Services to resolve complaints and improve device performance and customer experience.
Manage day-to-day document control across procedures, work instructions, and forms/records.
Support document review, revision, routing, approval, archival, and change-control processes.
Assist with monthly internal quality-system audits.
Support CAPA documentation, tracking, and action-item follow-up.
Support preparation and coordination for external and regulatory audits or inspections.
Maintain the QMS software platform, especially training management and document control functionality.
Manage quality operations and QMS workflows using observations and data trends.

Requirements

What you’ll need

Bachelor's degree required.
Master's degree in Regulatory Affairs, Quality Systems, or a related field preferred.
Minimum of 2 years of experience in the medical device industry.
Familiarity with FDA 21 CFR 820 and ISO 13485 requirements.
Experience with complaint handling, document control, or QMS software (eQMS) strongly preferred.
Experience supporting internal audits or CAPA processes is a plus.
Analytical thinking and problem-solving skills.
Proficiency in Microsoft Office suite.
Experience working in a fast-paced environment.
Excellent organizational skills and high attention to detail, particularly in documentation review.
Excellent English written and verbal communication.
Strong collaboration skills and team orientation.
Ability to present data and articulate ideas in front of an audience.
Ability to adapt quickly to change and thrive in a fast-paced environment.

Benefits

Comp & perks

Individual Bonus Opportunity
Equity Options
Flexible Paid Time Off (Guaranteed four (4) weeks of PTO)
Paid Sick Leave (up to forty (40) hours annually)
Fully Paid Parental Leave (twelve (12) weeks for birthing parents, eight (8) weeks for non-birthing/adoptive parents)
Competitive Medical, Dental, and Vision plans – Podimetrics covers 80% of premiums.
Health Savings Account with employer contribution
Employee Assistance Program - Free, confidential advice for team members who need help with stress, anxiety, financial planning, and legal issues.
401k
Life Insurance - Podimetrics pays 100% of the cost of Basic Life & Personal Accident
Disability insurance – Podimetrics pays 100% of the cost of Short-Term and Long-Term Disability Insurance
Additional life insurance, critical illness, and accident coverage are available