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, radiometers, and leak testers
Experience with eQMS and ERP systems, preferably MasterControl and SAP
Knowledge of lean manufacturing and Six Sigma principles is a plus
CQE (Certified Quality Engineer) or similar certifications are desirable
Experience in the medical device field preferred
Skills and Competencies:
Ability to read technical drawings, specifications, GD&T
Proficiency in statistical analysis software (Minitab, JMP, Excel) and tools
Familiarity with risk management tools (FMEA, fault tree analysis)
Confidence with Microsoft Office applications
Rigorous attention to detail with strong organizational and interpersonal skills
Strong verbal and written communication skills with the ability to work both independently and within a team environment
Strong analytical and problem-solving skills
Excellent communication and interpersonal skills
Can-do attitude with a willingness to take initiative and solve problems creatively, independently and efficiently
Ability to handle multiple assignments in a fast-paced environment
Ability to uphold a high standard for professionalism
Working Conditions:
Office and manufacturing floor environments.
Occasional travel may be required (including supplier visits or audits).
Must comply with all safety and quality standards and procedures.
Benefits
What We Offer:
Competitive salary and benefits package.
Opportunities for professional growth and development.
Supportive and collaborative team environment.
On-the-job training and mentorship.
How We Hire:
Allurion welcomes candidates from all backgrounds. We're committed to a fair hiring process free from discrimination. If your experience is close (even if not a perfect fit) to what we're looking for, please consider applying. Experience comes in many forms - skills are transferable, and passion goes a long way. We know that diversity makes for the best problem-solving and creative thinking, which is why we're dedicated to adding new perspectives to the team and encourage everyone to apply.
