ReShape Lifesciences Inc. is America's premier weight-loss solutions company, offering an integrated portfolio of proven products and services that manage and treat obesity and metabolic disease. Our team is driven by a passion to help patients learn how to make long-term healthy living a part of their everyday lives. Our portfolio includes the FDA-approved Lap-Band program, the investigational ReShape Vest System and the recently launched reshapecare
virtual health coaching program.
Join us as we partner with clinicians to implement our innovative, non-invasive weight loss procedure and one-on-one support that helps inspire patients on their journey towards successful, long-lasting weight loss. We are located in beautiful San Clemente, California, and offer a hybrid work environment. THE ROLE
ReShape Lifesciences has a fantastic opportunity for a Quality Specialist (Complaints) to join our growing team. This role is responsible for receiving, documenting, evaluating and coordinating investigations of customer complaints associated with ReShape Lifesciences' products. The Quality Specialist (Complaints) is also responsible for tracking and trending customer complaints and periodically reporting on those results, while working with cross-functional teams to evaluate customer complaints and evaluate the need for medical device reporting (MDR) and EU vigilance reporting.
WHAT YOU'LL DO
- Establish and maintain complaint files and databases for all customer complaints in accordance with U.S. and international regulations; make updates as necessary to ensure compliance with regulations.
- Evaluate event(s) to determine if the event qualifies as a complaint; escalate complaint to appropriate parties as needed.
- Coordinate with cross-functional departments, including but not limited to, Customer Service, Regulatory Affairs and Quality to gather root cause determinations and properly document complaint closure.
- Interface with customers when necessary to obtain additional information to support complaint investigation and product returned for investigation.
- Ensure that all complaints are properly evaluated for device reporting (MDR) and vigilance reporting; submit MDR and vigilance reports, as needed.
- Work with Quality team to develop, prepare, and analyze trend reports for complaints, as required.
- Ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, and other worldwide regulatory agencies.
- Draft response communications to inquiries from regulatory bodies as needed.
- Support internal and external audits (i.e. FDA, ISO, EU MDR, supplier).
- Assist with other Quality and Regulatory Affairs functions as needed, including special projects
WHAT YOU'LL NEED
- Bachelor's Degree in a technical or scientific field strongly preferred
- (or Associates Degree with at least three years of implantable medical device experience)
- Experience working in complaint handling, including receiving, documenting, performing and coordinating evaluations of complaints
- Experience working in medical devices, including determination of MDR reportability
- Strong customer service and reporting/ analysis skills
- Must be familiar with Quality Standards, including ISO13485
WHAT WE OFFER
- Hybrid work environment
- Business casual dress code
- Corporate-sponsored virtual team building events
- Medical, dental, vision and life insurance
- FSAs, HSAs, long-term and short-term disability
- 401(k) plan
- Employee assistance plan (EAP)
- Employee Stock Options