Quality Associate

Quality Associate

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:

• 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.

• 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, ensuring documents remain current, accurate, and audit-ready.
• Maintain document control records in accordance with change control procedures and quality system requirements.

• Assist with the internal audit program, including conducting monthly audits within the quality system.
• Provide support for corrective and preventive actions (CAPA), including documentation, tracking, and follow-up on action items.
• Support preparation and coordination for external and regulatory audits or inspections as needed.

• Assist in maintaining the QMS software platform, with a focus on training management and document control functionality.
• Manage day-to-day quality operations and maintain QMS workflows, incorporating observations and data trends as they arise.

Qualifications:

• 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, with 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.
• Demonstrated ability of analytical thinking and problem-solving skills.
• Proficient in the use of 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.

Critical Competencies:

Critical Thinking: Demonstrates analytic and problem-solving skills and understands the impact of individual decisions on other parts of the organization.

Attention to Detail: High attention to detail and a meticulous, organized approach to documentation review and document control.

Communication Skills: Excellent written and verbal communication skills. Ability to present data and articulate ideas in front of an audience.

Resourcefulness: Finds creative solutions to difficult problems, doing a lot with a little.

Teamwork: Respects colleagues and works well within and across teams. Motivates team members to achieve high performance through collaboration and fellowship.

Adaptability: Embraces and adjusts quickly to change. Ability to work and thrive in a fast-paced environment.

Benefits:

• Base Pay: $65k - $85k base salary commensurate with experience
• 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

Podimetrics is committed to a diverse and inclusive workplace. We are an equal opportunity employer and do not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.