Quality Associate

This is a fully remote position, open to applicants in United States.

📋 Description

• Evaluate daily patient feedback and assess its compliance with FDA and ISO 13485 standards for formal complaints.

• Initiate complaint documentation and carry out preliminary investigations within the quality management system.

• Contribute to post-market surveillance by analyzing device issue data and tracking recurring or emerging performance challenges.

• Monitor field devices remotely to detect potential issues and facilitate prompt device replacements.

• Collaborate with Device Operations, Sustaining Engineering, and Clinical Support Services to address complaints and enhance device performance and customer satisfaction.

• Oversee daily document control related to procedures, work instructions, and forms/records.

• Assist with the review, revision, routing, approval, archival, and change-control processes for documents.

• Aid in conducting monthly internal quality-system audits.

• Support the documentation, tracking, and follow-up of CAPA actions.

• Assist in the preparation and coordination for external and regulatory audits or inspections.

• Maintain the Quality Management System (QMS) software platform, focusing on training management and document control capabilities.

• Oversee quality operations and QMS workflows by utilizing observations and data trends.

⛳️ Requirements

• A bachelor's degree is required.

• A master's degree in Regulatory Affairs, Quality Systems, or a related field is preferred.

• At least 2 years of experience in the medical device sector.

• Knowledge of FDA 21 CFR 820 and ISO 13485 standards is essential.

• Strong preference for experience in complaint management, document control, or QMS software (eQMS).

• Experience in supporting internal audits or CAPA processes is advantageous.

• Strong analytical thinking and problem-solving abilities.

• Proficiency in Microsoft Office Suite.

• Experience in a fast-paced work environment.

• Exceptional organizational skills and meticulous attention to detail, especially in documentation review.

• Excellent written and verbal communication skills in English.

• Strong teamwork and collaboration skills.

• Ability to present data and articulate concepts effectively in front of an audience.

• Capability to quickly adapt to changes and succeed in a dynamic 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 support for team members dealing with stress, anxiety, financial planning, and legal matters.

• 401k

• Life Insurance - Podimetrics pays 100% of the cost of Basic Life & Personal Accident coverage.

• Disability insurance – Podimetrics covers 100% of Short-Term and Long-Term Disability Insurance costs.

• Additional life insurance, critical illness, and accident coverage options are available.