Quality Systems ManagerJuly 20, 2018
Allurion Technologies is a rapidly growing medical device company located in Natick, Massachusetts. The Company developed and markets the Elipse™ Device, an innovative device for the treatment of overweight and obese patients. The device is placed in a 15-minute office visit and does not require surgery, endoscopy or anesthesia for placement or removal. The Elipse Device was recognized as the top emerging technology of 2016 by the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). Search Elipse Balloon online or visit our website www.allurion.com for further information.
ROLES AND RESPONSIBILITIES
Allurion is seeking an experienced medical device professional to lead the Company’s quality assurance team. The ideal candidate will have five or more years of quality assurance leadership experience. He/she will have successful management and supervisory experience, will be a self-starter who is eager to roll up his/her sleeves and engage at the ground level.
Specifically, this individual will:
- Develop, implement, and maintain all aspects of the QMS meeting the requirements of the FDA, ISO 13485, the EU Medical Device Regulation and the Canadian Medical Device Regulations.
- Direct internal audits to monitor the effectiveness of the quality management system.
- Ensure awareness of regulatory and customer requirements throughout the company.
- Educate and train employees in quality management activities and systems.
- Control and improve the Part 11 compliant company’s documentation system.
- Ensure that products are manufactured in accordance with internal procedures and meet the requirements set forth in the applicable regulations and standards.
- Revise supplier quality agreements and manage supply chain, as required.
- Conduct supplier selection and qualification and perform on-site audits of critical suppliers.
- Act as liaison with customers, regulatory agencies and notified bodies for regulatory submissions, responses to inquiries, and site inspections.
- Manage the complaints and vigilance reporting processes and all CAPA related activities..
- Actively participate in risk management activities and assure compliance with ISO 14971.
- Guide and manage the quality control, quality assurance and document control functional areas and staff on a day-to-day basis.
- Perform root-cause analysis to identify process improvements and corrective actions.
- Monitor and interface with vendors and customers regarding quality control issues and to assure corrective actions are implemented.
- Report quality issues and recommended corrective actions to the management team.
- Bachelor’s degree, preferably in technical or scientific discipline such as mechanical engineering, electrical engineering, manufacturing engineering, or similar
- Five years’ experience in quality management systems implementation within a medical device manufacturing environment. Experience with Class III, PMA (USA) or Class IIb (EU) or higher devices preferred.
- Five years’ working experience within a GMP facility while meeting FDA requirements.
- Proven, hands-on track record of successful QMS program management within a medical device startup organization.
- Demonstrated leadership and management skills.
- Excellent written and oral communication skills.
COMPENSATION AND BENEFITS
- Salary will be commensurate with prior experience
- Comprehensive medical, dental, vision, life and disability insurance
- Tuition reimbursement
- Newborn baby care allowance
- Generous holiday schedule
- 3 weeks paid time off
- Stock options
- Company-matched 401K savings plan
Must be authorized to work in the US
If you are a qualified applicant, please submit your resume to: HR@allurion.com
Allurion is an equal opportunity employer.
PLEASE NOTE: We are not using agencies to fill this opportunity.