Quality Assurance Manager

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

📋 Description

• Report to the Director of Quality Assurance and assist in the development and expansion of UpDoc’s quality management system.

• Lead internal audits, conduct gap assessments, and ensure the closure of action items for periodic QMS evaluations.

• Oversee the management and upkeep of Design and Development Files for products regulated by the FDA.

• Manage quality training initiatives, guide team members on the usage of the quality system, and monitor training compliance as well as QMS action items.

• Develop and enhance quality systems and SOPs in accordance with cGxP, ISO 13485, and other relevant standards.

• Take ownership of and manage UpDoc’s Non-Conformance Reports (NCR), Corrective and Preventive Actions (CAPA), and post-market surveillance procedures.

• Administer and maintain UpDoc’s electronic Quality Management System (eQMS), Qualio.

• Collaborate with various departments to ensure the execution of change implementation action items.

• Provide assistance or support to the customer support team as necessary.

• Expand the quality function gradually as the company grows.

⛳️ Requirements

• Excellent communication skills and a proven history of cultivating a quality-focused culture from the ground up.

• Familiarity with fundamental QMS concepts and medical device regulations, including 21 CFR 820, ISO 13485, and ISO 14971.

• Previous experience in implementing or enhancing quality processes within a medical device or digital health organization.

• A minimum of 7 years in a regulated medical device setting, with at least 5 years in an FDA-regulated environment.

• Experience with software is preferred.

• Bachelor’s degree in Computer Science, Life Sciences, Engineering, or equivalent experience.

• Proficiency with common software startup tools and platforms such as Jira, Linear, Slack, and Google Workspace.

• Professional certifications such as ASQ or RAPS are highly desirable.

• ISO 13485 Auditor certification is highly preferred.

• Experience with Software as a Medical Device, particularly IEC 62304 and IEC 82304, is highly desired.

• Experience in early-stage or rapidly growing startups, specifically in building QMS processes from the ground up, is highly sought after.

• Familiarity with HIPAA and SOC 2 regulated environments is highly desirable.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Flexible work hours and remote work options.

• Opportunities for professional development and growth.

• Comprehensive health benefits, including medical, dental, and vision coverage.

• Collaborative and inclusive company culture.