Senior Quality Engineer

Job Purpose

The Senior Quality Engineer will be a key member of the QA organization at a growing medical device company that develops and manufactures 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) compliance with respect to QMS and production-related records and documentation.
• Support Quality Management in preparing for and conducting site visits from regulatory agencies or other accrediting bodies. This involves ensuring that our documentation and practices meet regulatory requirements and that we are prepared to demonstrate compliance during inspections
• Conducting required periodic review/inspection assessments of QMS documentation (e.g. executed design, development, production, and distribution forms for compliance to regulations such as US 21CFR11, US 21CFR820, QMSR, and other requirements as applicable)
• Oversee and handle various short and long-term QA-related projects, and support or lead other tasks and responsibilities, as assigned.

Required Skills & Experience

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

5+ years experience with FDA and ISO 13485 regulated medical device product development

• Practical knowledge or experience with design controls, production, and process controls, CAPA, complaint handling, and post-market / vigilance requirements
• Experience with MDSAP, ISO 13485, ISO 14971, 21 CFR 820, FDA QSR, Health Canada, TGA, and EU MDR.
• Ability to author, review, and update technical or QMS documents.
• Experience with software verification, validation, and software hazards analysis.
• Experience or practical knowledge of IEC 62304 and agile methodologies is preferred.
• Experience with software quality and software as a Medical Device (SaMD) is a plus
• 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 are a must
• Excellent communication and problem-solving skills
• Comfortable working in a fast-paced and agile environment with distributed teams across different time zones

Required Education

• BS Degree in Mathematics, Business, Computer Science and Engineering or equivalent

Compensation & Benefits

Welldoc offers a competitive compensation package, which, in addition to salary, includes generous PTO, medical insurance, and opportunities for employee development and advancement.