Quality Associate

Job Title: Quality Associate

Department: Quality and Regulatory
Location: Remote

Reports to: Director, Quality and Regulatory

Key Relationships: Sr. Quality Engineer, Device Operations, Sustaining Engineering, Clinical Support
About Podimetrics :

Founded in 2011, Podimetrics set out on a mission to improve patient lives through early detection and prevention of diabetic foot ulcers, the leading cause of lower limb amputations. Podimetrics has since evolved to become a rapidly growing virtual care management company with advanced technology and patient-centered services.

Today, Podimetrics teams with and provides solutions to patients, payers and providers that alleviate the health and financial implications of diabetic foot complications in high-risk populations. We are a mission driven, financially responsible enterprise that enables patients to stand on their own feet and live more independent and fulfilling lives.
Core Values:

- Mission First: We are here to drive critical change, bring hope and compassionate care to those in great need.

- People Matter Most: We advance our mission by caring for our people (colleagues, patients, providers, customers and stockholders), treating them with kindness and respect.

- Courageous Action: We are driven to act and demand mutual accountability. We believe that missteps foster learning and iterative improvement.

- Healthy Debate: We commit to transparent discussion and resulting decisions. The very best decisions come from differing points of view, requiring good intentions, mutual trust and no ego.

- Deep Curiosity: We are always striving to learn more and do better. We question if the best we have ever done couldn’t be improved further.

Role Description:

We are seeking a highly driven, organized, and detail-oriented Quality Associate to support a broad set of responsibilities across the Quality and Regulatory Affairs department. This role sits at the center of post-market surveillance, complaint handling, document control, and audit/CAPA support, and requires fluid movement between hands-on patient device data, formal quality system documentation, and cross-functional collaboration. The Quality Associate will work closely with Regulatory Affairs, Quality Engineering, Device Operations, Sustaining Engineering, and Clinical Support Services on a day-to-day basis. The ideal candidate is analytical, highly organized, and energized by building structure into a growing quality system — triaging patient feedback into formal complaints, keeping the document control environment current and audit-ready, supporting proactive post-market surveillance through data trending and remote device monitoring, and assisting with internal audits and corrective actions.
Key Responsibilities:

Complaint Handling & Post-Market Surveillance

- Review incoming patient feedback on a daily basis and determine whether it meets the criteria for a formal complaint per FDA and ISO 13485 requirements.

- Initiate the complaint process within the quality system for qualifying feedback, including opening complaint records and conducting initial investigations.

- Support Quality Engineering with post-market surveillance activities, including trending device issue data and maintaining visibility into recurring or emerging performance issues.

- Conduct remote monitoring of devices in the field to proactively identify potential issues and initiate timely device replacements, ensuring patients experience uninterrupted use of Podimetrics devices.

- Coordinate with Device Operations, Sustaining Engineering, and Clinical Support Services to resolve complaints and drive improvements to device performance and customer experience.

Document Control

- Own day-to-day document control responsibilities across multiple document tiers within the quality management system (e.g., procedures, work instructions, and forms/records).

- Support document review, revision, routing, approval, and archival processes, ensuri