Quality Assurance Specialist

Position: Quality Assurance Specialist

Department: Regulatory Affairs and Quality Systems

Hiring Manager: Director of Quality

Company: Amalgam Rx, Inc.

Company Overview: At Amalgam Rx, our mission is to empower patients and providers to make the best decisions possible – in the provider workflow and in patients’ everyday lives. Through a suite of EHR Solutions and a modular SaMD platform, Amalgam enables the leading life sciences companies, health plans, and provider organizations to collaboratively reimagine healthcare and create lasting change across the ecosystem.

We blend art, science, and technology to create and distribute exceptional – often regulated – digital products, including digital medicine, patient identification, clinical decision support, clinical trial recruiting, and more. Our modular platform enables rapid solution creation and is directly integrated in the EHR workflow – allowing for rapid scale across health systems and around the world. Today, Amalgam’s algorithms and applications support nearly 10 million patients across 4 continents and have helped providers make over 50 million decisions.

We seek brilliant minds and passionate individuals to help us realize our vision and continue our rapid growth. We challenge each other, learn from each other, work hard, and have fun together. You’ll come to work every day with an opportunity to break new ground, and if you believe in the limitless potential of digital health, you’ll love the team.

Job Purpose: The Quality Assurance Specialist will ensure the complaint handling process for Amalgam’s portfolio of products is maintained and compliant according to QMS procedures and applicable regulations. The role will serve as the quality representative for managing customer feedback, complaint handling and vigilance processes.  This role may also support additional quality processes such as document control, non-conformances, supplier controls or other areas within the eQMS system as assigned. This team member is thorough and has a keen eye for detail.

Position Type: Full-time position, 40 hours a week

Location: U.S. remote.

Job Responsibilities:

• Records and evaluates customer feedback and complaint submissions
• Communicates with customers, partners and affiliates to acquire relevant complaint information
• Coordinates with internal departments (Regulatory Affairs, Quality Assurance, Medical Affairs, Engineering) to incorporate vital input into complaints reports
• Records and provides regulatory reportability decisions on complaints
• Ensures timely processing of complaints
• Generates and submits medical device event reports to appropriate authorities and government agencies as required by applicable laws and regulations
• Responds to inquiries regarding medical device / vigilance report submissions associated with device malfunction or serious injury
• Reviews and prepares complaint files for closure
• Participates in inter-departmental cross-functional projects
• Manages monthly data metrics, user logs and data reconciliations for trending and management review
• Support the maintenance of the quality management system in accordance with 21 CFR Part 820, 21 CFR 803, MDR, ISO 134815:2016, MDSAP
• Participate in internal and external audits of departments/processes for compliance with regulatory requirements.
• Support additional eQMS processes such as document control, training, records management

Desired Attributes:

• A minimum of 3 years of experience in medical device/IVD complaint handling and vigilance reporting
• Experience with software products, SaMD, Mobile Medical Applications
• Familiarity with quality system documentation, eQMS software, and good documentation practices
• Results-oriented, with an ability and flexibility to manage multiple processes simultaneously
• Ability to distill and communicate complex information
• Ability to execute in a fast-paced environment
• Data driven and analytical
• Uncompromising with respect to quality in all regards
• Team player, good listener and capable of building strong relationships
• Enthusiasm, high energy, and determination to succeed
• Proven problem solver
• Self-starter, able to work independently or in a team environment
• Unquestionable integrity and ethics

Required Education: Bachelor’s Degree in Life Sciences, Engineering, or Computer Science from an accredited college or university.

Compensation Benefits: Amalgam offers competitive compensation, outstanding benefits, plus equity ownership for all employees.

Apply to Careers@amalgamrx.com or email our Director of Quality.