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Quality Engineering Manager
2 months ago
Allurion is a leading healthcare company dedicated to transforming the way obesity is treated. Our mission is to make a lasting impact on the world by providing innovative solutions for a healthier future.
Job SummaryWe are seeking a highly skilled Senior Quality Assurance Engineer to join our quality assurance team. As a key member of our team, you will play a vital role in ensuring the safety and success of our medical devices.
Key Responsibilities- Lead or contribute to significant projects, processes, or improvements, collaborating closely with key stakeholders.
- Support the Manufacturing Quality Team by troubleshooting issues, conducting root cause investigations, and providing assistance as needed.
- Offer guidance to R&D and manufacturing teams on verification, sampling plans, and usability testing to ensure compliance with internal and external requirements.
- Provide technical expertise and guidance on relevant medical device standards, ensuring cross-functional teams meet or exceed regulatory requirements.
- Bachelor's degree in Engineering, Science, Quality Management, or a related technical field.
- 5+ years of experience in medical device design, development, and manufacturing.
- Demonstrated proficiency in specific areas of medical device engineering.
- Proven track record of implementing process improvements and continuous learning.
- Mastery of Quality Management System (QMS) standards and experience with ISO 13485 and FDA regulations.
- Strong statistics knowledge and data analysis skills.
- Ability to thrive in a fast-paced environment with changing priorities and manage multiple assignments effectively.
- Competitive compensation package.
- Paid time off and flexible work arrangements.
- Training and career development opportunities.
- Global Employee Assistance Program and Total Wellbeing Platform.
- Employee Stock Purchase Program.
- Volunteer Time Off.
Allurion's office in Natick offers a hybrid full-time schedule, with 4 days onsite. We believe in the power of both virtual connections and in-person interactions, fostering a dynamic culture of collaboration and innovation across our global team.
