WellDoc, Inc.

  • Quality Assurance Manager

    Job Locations US-MD-Columbia
    ID
    2019-1097
    # of Openings
    1
    Category
    Management
  • Overview

    An Opportunity to Pioneer Innovation in Chronic Care Management

    If you’ve ever wished you had a job that could make a difference in someone’s life, this is your chance to support a new approach to chronic care management.  Welldoc is pushing the industry forward – helping health plans, health systems and employers move beyond traditional health coaching and consumer mobile apps. As a pioneer in digital therapeutics, we’re helping to simplify people’s healthcare experience, drive improved self-care and support consumer empowerment.

    Welldoc has two randomized clinical trials and 40+ peer-reviewed studies that clearly demonstrate the clinical impact of our solution.  Welldoc was the first to receive FDA clearance for a diabetes software solution (Class II Medical Device) and continues to drive market innovation across conditions.  In an extremely crowded space, we offer differentiated approaches while ensuring value for our clients through performance-based payments.

    Join a winner!  In 2019, Welldoc’s precision, real-time feedback solution was recognized as Best Personal Health App (MedTech Breakthrough Awards) and Best Established App (Digital Diabetes Congress).  If you are passionate about driving the health care industry forward to better improve the lives of patients, members and employees, let’s talk!  

    Responsibilities

    The Quality Manager will be a key member of the QA organization of a growing medical device company developing and manufacturing software as medical devices. The position will manage Quality Assurance activities related to product development, new product introduction and manufacturing and provide leadership in fostering a culture of quality.

     

    Key Responsibilities

    • Manage, improve and maintain quality methodologies, processes and procedures. Lead continuous improvement initiatives and projects to improve processes and upgrade Welldoc’s quality documentation electronic system to meet expanding quality activities for commercialization.
    • Establish and maintain effective cross functional team communications to advance quality.
    • Develop master plan for Welldoc’s quality initiatives, and coordinate, manage and track QA team’s efforts, ensuring milestones are met within defined budgets and schedules.
    • Manage and coordinate inspection, software quality and finished products per established quality specifications.
    • Assist with improving key company quality sub-systems such as supplier management, production and process control, risk management, CAPA, NCMR, and complaint handling and assure that best practice software development lifecycle process is established and maintained.
    • Participate in department and inter-department planning and management teams and work cross-functionally to improve processes within the Welldoc organization.
    • Develop and trend key metrics to monitor the health of various quality sub-systems and overall quality system. Compile and analyze data, and document, summarize and report quality findings to senior/executive management and new product development teams, and recommend appropriate actions.
    • Coordinate Welldoc activities for any external audits and inspections, including FDA, MDD, MDR, MDSAP and ISO13485. Maintain and ensure effective standard operating procedures are in place for Medical Device-related auditing and inspections.  Establish and conduct audit and inspection readiness training for all Welldoc parties, and ensure readiness through other means such as mock audits.  Conduct 3rd party audits to ensure adherence to Welldoc requirements.
    • Ensure compliance and employee adherence to internal SOPs, policies, external regulations (e.g., 21CFR 820 and ISO13485) and established best practices. Ensure product development and design control activities, including verification and validation, are performed in compliance with internal procedures and standards.
    • Partner with R&D, Engineering, Clinical, etc., in the development of new products including establishing standards for these products. Provide input on content and quality of product requirements, design, and test protocols.
    • Develop or approve recommendations to change systems, policies, and procedures; ensure timely and accurate implementation. Assure systems are in compliance with ISO and FDA quality system regulations.  Responsible for understanding, tracking and complying with external regulations and standards and updating procedures to conform to latest versions.
    • Manage Quality Assurance team. Define priorities, delegate responsibilities and balance planning efforts with day-to-day demands.  Identify and obtain staff capabilities needed to accomplish objectives.  Responsible for ensuring that department understands and complies with quality standards and requirements, as documented.
    • Oversee and handle various short and long-term QA-related projects, and support or lead other tasks and responsibilities, as assigned.

    Qualifications

    To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

    • BS Degree in Mathematics, Business, Computer Science or Engineering or equivalent
    • 5+ years’ experience with FDA and ISO regulated product development and ISO quality systems, including Design Controls, Production and Process Controls, CAPA and complaints
    • Experience with MDSAP, ISO 13485, ISO 14971, FDA QSR, Health Canada, TGA and EU MDR
    • Experience with software validation and software hazards analysis preferred.
    • Experience with software quality and software as a Medical Device (SaMD) a plus
    • Experience with diabetes devices a plus
    • Must have 2 years managerial experience in a quality assurance position
    • Proven track record of success building, leading, and managing a functional and technical QA team
    • High attention to detail and meticulous record-keeping
    • Ability to work both independently and as part of a highly integrated team
    • Multitasking and project organization skills a must
    • Excellent communication and problem solving skills
    • Comfortable working in a fast-paced and agile environment

     

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