Senior Quality Engineer

About Us

We are a global team of like-minded Med-Tech professionals focused on patient centric solutions in a collaborative environment leading to excellent outcomes. We have developed an advanced and unique heart failure therapy technology in the BrioVAD® Left Ventricular Assist System (LVAS). We are introducing the BrioVAD LVAS to Heart Failure clinicians for use with the large number of indicated and untreated patients who could benefit from chronic mechanical circulatory support. The initiation of our INNOVATE™ Trial in the US is only the beginning. We are building a team to develop advanced technology intended to further improve patient outcomes, increase therapy acceptance, and enable chronic MCS therapy to be accessible to more patients across the globe.

Job Summary

BrioHealth Solutions is seeking a dedicated and experienced Senior Quality Engineer to support the development, implementation, and ongoing maintenance of our Quality Management System (QMS). This role is pivotal in ensuring compliance with FDA QMSR, ISO 13485, EU MDR, and other regulatory standards critical to our medical device operations. The ideal candidate will be responsible for managing internal audits, organizing management review meetings, and tracking essential quality documentation for product registrations and regulatory submissions. In addition, you will collaborate cross-functionally to drive continuous improvement efforts and ensure the quality of our heart failure therapies meets the highest standards. This is an onsite position located in Burlington, MA, with up to 15% travel required.

Responsibilities

Quality Management System (QMS)

• Support the development, implementation, and maintenance of the company's Quality Management System (QMS) to ensure compliance with FDA QMSR, ISO 13485, EU MDR, and other applicable regulations and standards.
• Organize and conduct internal audits to evaluate the effectiveness of the QMS and ensure adherence to regulatory requirements.
• ​Aid in the organization of management review meetings and is responsible for tracking action items, ensuring timely closure, and follow-up on the review outputs.
• Assist in the preparation and management of essential quality system documents for product registrations, including domestic and FDA submissions.
• Play a key role in managing relevant medical device quality regulations, including the evaluation, update, training, and implementation of related quality system documents.
• ​Assist in coordinating external audits, including system certification inspections, to ensure compliance with quality standards.
• Contribute to the development, tracking, and monitoring of key performance indicators (KPIs) related to quality, ensuring continuous improvement.
• Collect and analyze data from quality management workflows and provides detailed reports to the Quality Assurance (QA) team, functional leaders, and senior management.
• Deliver training and ongoing support to ensure employees understand and adhere to quality system processes.

Cross Functional Collaboration

• Lead cross-functional teams with persistence and determination, driving the integration of new process technologies aimed at improving quality management workflows and product quality.
• Work closely with departments such as R&D, manufacturing, supply chain, and regulatory affairs to ensure alignment with quality objectives and address department-specific needs.

Additional Responsibilities

• Conduct quality assurance audits and assessments to verify compliance with established quality management system requirements.
• Perform statistical analysis on quality data to identify trends and areas for improvement and drive the implementation of corrective and preventive actions (CAPAs).
• Supports regulatory inspections and audits, addressing non-conformities and ensuring the implementation of corrective actions.
• Stay current with evolving regulations, guidelines, and industry best practices related to medical device design, development, and quality assurance.

Qualifications

• Bachelor’s degree in Engineering, Science, or a related field.
• At least 5 years of hands-on experience in Quality Management Systems (QMS) within the medical device industry, specifically with Class III sterile medical devices.

Nice to Have

• Master's degree or higher in Engineering, Science, or a related field.
• Experience in quality management systems, with a focus on Class III active implantable and life-supporting medical devices.
• Strong expertise in design control processes, risk management principles, and quality management systems.
• In-depth understanding of relevant regulatory requirements and industry standards, including FDA QSR/QMSR, ISO 13485, EU MDR, and ISO 14971.
• Results-driven with a strong focus on aligning quality initiatives with business priorities.
• Proven ability to lead and influence cross-functional teams in a highly matrixed organization to achieve quality and business objectives.
• Proficient in utilizing statistical methods and tools for data analysis and driving quality improvement initiatives.
• Excellent verbal and written communication skills, with the ability to effectively present to senior leadership and engage teams.
• Strong interpersonal skills for building collaborative relationships across all levels.
• Certifications

-ASQ Certified Quality Engineer (CQE).

-DMAIC Lean / Six Sigma Certification, with demonstrated success in leading DMAIC projects to drive continuous improvement.