Sr Quality Engineer

Sr Quality Engineer Job Purpose The Sr. Quality Engineer 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 own, manage, or support key areas of Quality Management System (QMS), including but not limited to new product introduction, Design Control, change management, CAPA, complaint handling, suppliers, and training. This role will also interface with cross-functional teams and external partners. Responsibilities Manages and supports Controlled Documents on Welldoc’s electronic QMS (eQMS) and Learning Management System (LMS). This means you'll be responsible for managing these digital platforms that help us maintain high standards in how we control processes, documents, operate, and how we train our teams to remain compliant with SaMD regulations. Play the role of a Quality Lead on product development core teams to advocate QMS requirements and to provide guidance to the project team to ensure the Welldoc Product Development activities follow the established Quality Management Processes. Provide, improve, and maintain quality methodologies, processes, and procedures. Support continuous improvement initiatives and projects to improve processes and upgrade Welldoc’ s QMS to meet expanding quality activities for commercialization. Establish and maintain effective cross-functional team communications to advance quality. Proactively provide inputs to develop a master plan for Welldoc’ s for our quality initiatives and objectives, following directions from leadership to drive improvements across the organization. Improving key aspects of our quality systems will be part of your daily tasks. This includes areas like Design control, supplier management, production and process control, document control, risk management, Corrective and Preventive Actions (CAPA), and handling complaints and ensuring that our software development lifecycle processes meet best practices. Contribute to QMS management reviews in a timely and effective manner. Interface with Quality Assurance / Quality System peers in external partner organizations to maintain strategic goals Manage and support internal and external audits and inspections, including those from regulatory bodies like the FDA and MDSAP. Ensure that our operations and documentation comply with internal Standard Operating Procedures (SOPs), policies, good documentation practices, and external regulations. 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 comply with ISO and FDA quality system regulations.  Responsible for understanding, tracking, and complying with external regulations and standards, and updating procedures to conform to the latest versions. Maintain and update training programs on a timely basis and manage the configuration of controlled documents to ensure new and current employees are trained according to our QMS requirements and that all training materials are current and accessible. Manage Learning Management System (LMS) activities, including but not limited to: functional training curricula set up/updates, employee onboarding training setup/updates. Ensuring the proper issuance, retrieval, and archiving of controlled documents through our document management system is critical. Oversee the approval, distribution, modification, and retention of documents in accordance with our internal policies and regulatory requirements. Coordinate and distribute document revisions and review cycles for all documents, including delegation to the appropriate groups for review to ensure business continuity. Review and ensure good documentation practices (GDP) co ... (truncated, view full listing at source)