Quality Assurance Manager

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 enabling chronic MCS therapy to be accessible to more patients across the globe.

Job Summary

BrioHealth Solutions is seeking an experienced Quality Assurance Manager to oversee and enhance our Quality Management System (QMS), ensuring compliance with FDA QMSR, ISO 13485, EU MDR, and other global regulatory standards. This role involves leading a team of Quality Engineers, driving process improvements, supporting design transfer, and collaborating cross-functionally to uphold our commitment to product quality and patient safety. The ideal candidate will bring strong leadership, regulatory expertise, and a proactive approach to quality assurance in a fast-paced medical device environment. This role is based in Burlington, MA, with up to 25% domestic and international travel required to support business needs.

Responsibilities

Management Responsibilities

• Responsible for daily management of staff reporting to this position, which may include one or more Quality Engineers.

Quality Management System (QMS)

• Assist in establishing and maintaining the quality system to ensure that it meets the requirements of FDA QMSR, ISO 13485, EU MDR, and other relevant guidelines.
• Organize and carry out internal audits of the company's quality system to ensure regulatory compliance.
• Organize the company’s management review meetings and is responsible for tracking and closing the review output.
• Assist in the preparation of relevant quality system materials such as domestic registration of products and FDA registration.
• Responsible for the management of relevant regulations of the medical device quality management system, including but not limited to the evaluation, update, training and implementation of relevant quality system documents.
• Assist with coordinating the company's system certification inspection and external audit.
• Develop and monitor Quality KPIs.

Production Quality

• Provide input on product requirements, acceptance criteria, traceability, process monitoring, product evaluation, failure investigation and analysis of BrioHealth Solution products.
• Support and monitors the incoming, in-process and final inspection activities and associated processes.
• Help implement and maintain quality assurance processes to ensure compliance with applicable regulations and standards, such as FDA QMSR, ISO 13485, EU MDR, and other relevant guidelines.
• Support the Material Review Board (MRB) meetings; helps identify compliance gaps, conducts root cause analysis and corrective actions for non-conforming components.
• Ensure that product quality meets applicable requirements and device history records are complete prior to product lot release.
• Support the Change Control Board (CCB) meetings, and Initiates / executes Change Orders (COs) for areas of responsibility.
• Adhere to and promote adherence to established procedures.

Design Transfer

• Participate in design reviews as QA representative, ensuring compliance with QMS requirements.
• Work closely with R&D, Design Quality and Advanced Manufacturing Engineering (AME) to plan and execute design transfers to manufacturing.
• Support the AME/operations team with developing and implementing manufacturing plans to accomplish a robust design transfer from initial concept to full production for new products, product changes and enhancements.
• Support the AME/operations team with designing and developing manufacturing processes, associated equipment, tooling, and fixtures to meet business needs while enhancing process safety, quality, and productivity.
• Collaborate with the operations team to incorporate risk management principles into the process design and facilitate risk-based decision making.
• Assist the operations team with conducting process design and risk reviews to assess compliance with regulatory requirements, industry standards, and internal quality procedures.
• Play a key role in drafting and finalizing pFMEA, Design For Manufacturing / Assembly (DFM/DFA), and process control strategies.
• Assist with creation, execution and completion of all process validation activities (e.g., process development and execution of IQ/OQ/PQ).

Process Support and Improvement

• Provide support to the AME/operations team in troubleshooting, implementing production throughput and yield improvements, training on new products or processes, verifying documentation compliance.
• Support the creation of training materials and execution of training for manufacturing personnel for newly developed processes as needed.

Supplier Management

• Assist the supply chain team with building and maintaining strong relationships with suppliers for manufacturing materials, processes and equipment.
• Assist with identification and qualification of alternative suppliers, as needed.
• Assist AME and supply chain teams with implementing supply chain sustaining and cost reduction activities.
• Collaborate with suppliers to ensure their processes and products meet the necessary quality standards and regulatory requirements.
• Plan, coordinate and participate in supplier audits and assessments, addressing any identified non-conformances or quality issues.
• Support supplier qualification and selection processes by evaluating their quality systems, capabilities, and performance.

Cross-functional Collaboration

• Apply persistence and determination in organizing, managing, and motivating, cross-functional teams to implement and integrate new process technologies to help improve product quality.
• Work closely with various departments, including R&D, design quality, manufacturing, supply chain, and regulatory affairs, to understand and address their needs.

Other

• Identify technical risks, resource issues and proposed solutions while continuing to build trust at all levels of the organization.
• Collaborate with cross-functional teams to ensure adherence to design control processes throughout the product development lifecycle, including planning, design inputs, design outputs, verification, validation, and transfer to manufacturing.
• Apply risk management methodologies, such as ISO 14971, to identify, evaluate, and mitigate risks associated with the manufacturing process and use of medical devices.
• Conduct process audits and assessments to verify compliance with manufacturing procedures and quality management system requirements.
• Responsible for statistical analysis and trending of quality data to identify areas for improvement and implement corrective and preventive actions (CAPAs).
• Support regulatory inspections and audits, addressing any findings and implementing appropriate corrective actions.
• Stay updated with relevant regulations, guidelines, and industry best practices pertaining to medical device design, development, and quality assurance.

Qualifications

• Bachelor’s degree in engineering or science.
• Minimum of 5 years of direct quality assurance / production quality engineering experience within the medical device industry with Class III sterile medical devices.
• Proficient in FDA QSR/QMSR, ISO 13485, and EU MDR quality management system requirements.
• Strong understanding of design control processes, risk management principles, and quality management systems.
• Minimum of 3 years of management experience supervising technical staff.
• Strong leadership and influencing skills to drive results in a highly matrixed organization.
• Strong understanding of process validation.
• Highly results oriented and focused on business priorities.
• Excellent interpersonal skills.

Nice to Have

• Advanced degree in engineering or science.
• Quality assurance and production quality engineering experience with Class III active implantable or life-support medical devices.
• Lean Six Sigma (DMAIC) Certification with a proven track record of leading successful process improvement projects.
• Strong proficiency in statistical analysis and quality improvement methodologies.
• Exceptional presentation and communication skills, with the ability to convey complex information effectively.