Manufacturing Quality Engineer

Allurion is seeking a highly motivated and detail-oriented Manufacturing Quality Engineer to join our Quality Assurance team. This role is instrumental in maintaining the highest standards of quality and regulatory compliance in the manufacturing of the world’s first and industry-leading self-emptying gastric balloon for weight loss.

The successful candidate will possess a strong background in quality engineering, with demonstrated expertise in risk management and compliance within a regulated industry - preferably medical devices or pharmaceuticals. Key responsibilities include conducting risk analyses, performing root cause investigations, managing non-conformances (including containment, correction, and disposition), leading corrective and preventive actions (CAPAs), and overseeing calibration, environmental monitoring, supplier quality, device history record (DHR) reviews, and inspection and testing activities across incoming, in-process, and finished goods.

The Manufacturing Quality Engineer will support internal manufacturing operations while ensuring the highest levels of product quality and safety of our patients. This role offers the opportunity to contribute meaningfully to patient safety and product innovation in a growing medical device company with an expectation to work on-site in Natick, MA five days a week.

As the Manufacturing Quality Engineer, your responsibilities will include:

Quality Oversight

• Support day-to-day manufacturing activities by ensuring compliance with quality standards, procedures, and regulatory requirements (21 CFR Part 820, ISO 13485 & 14971, MDR)
• Serve as a quality representative on cross-functional manufacturing and process improvement projects and teams
• Oversee the quality of manufacturing and proactively identify opportunities for process and product improvements

Process Validation and Improvement

• Lead and support validation efforts (IQ/OQ/PQ) for new and existing manufacturing equipment and processes
• Analyze process data, identify trends, and implement corrective/preventive actions (CAPAs) to improve product quality and efficiency

Nonconformance and CAPA Management

• Investigate and resolve product and process nonconformances, ensuring timely root cause analysis, containment, correction, and implementation of robust corrective actions
• Participate in the CAPA process, including writing, reviewing, and approving CAPA reports

Documentation and Compliance

• Author and review quality-controlled documentation including SOPs, work instructions, inspection plans, and quality records
• Ensure accurate and compliant documentation in accordance with applicable internal processes and regulatory standards

Audits and Inspections

• Support internal and external audits, including FDA inspections and ISO audits
• Implement and monitor audit findings and assist with audit readiness

Supplier Quality Support

• Work with suppliers to ensure incoming materials meet specifications and quality standards
• Assist in supplier qualification, audits, and performance monitoring
• Perform physical inspection of components, in-process assemblies, finished products, and related documents during manufacturing in a controlled environment
• Provide final QA review and approvals for inbound & outbound shipments
• Perform environmental monitoring activities in support of a Class 8 Controlled Environment and microbiologically safe product
• Manage and maintain calibration schedules
• Review and approve Device History Records to support product release
• Initiate Nonconforming Material Reports and manage affected materials, processes, and suppliers
• Develop and maintain quality records
• Propose improvements to enhance quality and efficiency
• Implement modifications to Standard Operating Procedures (SOP's) where opportunities arise
• Maintain logs and databases related to the above functions

Requirements

Education and Experience:

• Bachelor’s degree in engineering (Mechanical, Biomedical, Industrial, or related discipline) or equivalent technical degree
• 3+ years of quality engineering experience in a regulated manufacturing environment, preferably medical devices
• Working knowledge of quality systems and regulations (21 CFR Part 820, ISO 13485, ISO 14971, etc.)
• Knowledge of thermoplastics, thin films, and stress mechanics
• Experience with various mechanical inspection and testing techniques, such as vision systems, surface plate set-up, hand tools, tensile testers, ra