Quality Associate

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $65k - $85k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

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Podimetrics

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2011

🏥 Healthcare

🏭 Manufacturing

⚕️ Healthcare Insurance

Healthcare • Manufacturing • Healthcare Insurance

Podimetrics is a healthcare company focused on preventing diabetic foot complications. It provides clinically-proven technologies and human-to-human support to prevent diabetic foot ulcers and amputations among patients with advanced diabetes. The company collaborates with healthcare providers, offering a SmartMat for home use that monitors foot temperature to detect early signs of inflammation, thereby facilitating rapid intervention. Podimetrics aims to reduce healthcare costs and improve patient mobility and quality of life through its innovative solutions.

📋 Description

• 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

• 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

• 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