- Bachelor's Degree Requirement: A bachelor's degree in Engineering, Science, Quality Management, or a related technical field is a minimum requirement for this role, ensuring a solid foundation in the necessary expertise.
- Extensive Experience: We seek a hands-on Quality Engineer with 5+ years of experience in medical device design, development, and manufacturing.
- Recognized Skills: Demonstrated proficiency in specific areas of medical device engineering is highly valued.
- Continuous Improvement: We value innovation and welcome individuals who have a proven track record of implementing process improvements.
- Expertise Maestro: Mastery of Quality Management System (QMS) standards is highly regarded.
- Verification/Validation Protocols: Experience in developing and executing verification/validation protocols is essential.
- Strong Statistics Knowledge/Data Analysis Skills: Ability to effectively utilize statistical methods for data analysis is highly valued.
- Certifications: Possession of auditing certification is preferred.
- Experience with Quality Operations: Previous experience working within a highly regulated industry, with particular emphasis on ISO 13485 and FDA regulations, is valued.
- Collaborative Skills: Excellent interpersonal and communication skills, along with the ability to collaborate effectively within cross-functional teams, are essential.
- Goal-oriented and Initiative-driven: Demonstrated goal orientation with a positive attitude and a proactive approach to problem-solving, displaying creativity, independence, efficiency, and attention to detail, is highly valued.
- Adaptability: Ability to thrive in a fast-paced environment with changing priorities, managing multiple assignments effectively, is essential.
- Professionalism: Upholding high standards of professionalism fosters a culture of excellence and integrity within the workplace, contributing to a positive and respectful work environment.
- Technical Proficiency: Confidence in utilizing Microsoft Windows, Microsoft Office, and Adobe Acrobat is essential.
- Competitive Package
- Paid Time Off
- Training and Career Development
- Global Employee Assistance Program & Total Wellbeing Platform
- Employee Stock Purchase Program
- Volunteer Time Off
- Benefits and perks are tailored to your country of residence
- Our office in Natick offers a hybrid full-time schedule, with 4 days onsite. At Allurion, we believe in the power of both virtual connections and in-person interactions, fostering a dynamic culture of collaboration and innovation across our diverse global team.
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Senior Quality Engineer - Natick, United States - Allurion
Description
Job Description
Job DescriptionWhy Allurion?We are overjoyed to be recognized as one of Deloitte's top 500 fastest-growing technology companies in the US But wait, there's even more excitement in store Get ready for an incredible new journey as we proudly announce our official public listing ALUR. This momentous milestone opens up a new era filled with boundless possibilities and remarkable growth for our company
At Allurion, our core values of Audacity, Grit, Authenticity, Accountability, and being Data Driven, combined with our passion for innovation, have fuelled our growth and will help us achieve our ambitious mission – ending obesity As part of a recognized Great Place to Work in the US, UK, France, Allurions engage as a collaborative global team while solutioning a critical healthcare challenge which affects millions. We are driven by purpose, motivated by individual challenge and growth, and energized by collective engagement and competitive rewards. We invite you to join us as we aim to transform the way obesity is treated and make a lasting impact on the world.
What will you be doing?As our Senior Quality Engineer, you'll play a vital role within our quality assurance team, reporting directly to the Quality Assurance Development Manager. Your responsibilities will include leading or contributing to several significant projects, processes, or improvements. You'll collaborate closely with key stakeholders, offering guidance and reviewing technical inputs and outputs for various tasks and projects.
Your primary focus will be to support the Manufacturing Quality Team by troubleshooting issues, conducting root cause investigations, and providing assistance as needed. Additionally, you'll offer guidance to R&D and manufacturing teams on verification, sampling plans, and usability testing to ensure that we meet or exceed both internal and external requirements. It's essential that you possess a working knowledge of relevant medical device standards and can guide cross-functional teams toward compliance.
Your contributions are pivotal in ensuring the safety and success of the Allurion Device. You'll be at the forefront of upholding our commitment to quality and driving ongoing growth at Allurion.
What we're looking for in you:Let's kickstart the day, maximizing our workday with ample time for lunch to recharge and refuel We're all about balance here, so your work experience will be tailored to support your best self, allowing you the flexibility you need. Your well-being matters to us
Diversity and Inclusion
Allurion is committed to a fair hiring process free from discrimination and we welcome candidates from all backgrounds. 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
To learn more about Allurion please visit our website
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