Career Opportunities

Position:

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Senior Risk Management Specialist

Quality Assurance

Franklin, WI

 

 

About Sientra

Headquartered in Santa Barbara, California, Sientra is a diversified global medical aesthetics company and a leading partner to aesthetic physicians. The Company offers a suite of products designed to make a difference in patients' lives by enhancing their body image, growing their self-esteem, and restoring their confidence. Sientra has developed a broad portfolio of products with technologically differentiated characteristics, supported by independent laboratory testing and strong clinical trial outcomes.

 

Our leadership is driven by decades of experience and skill that help bring your goals and aesthetic visions to life. We believe that shared expertise and values are essential components of success. We are seeking exceptionally talented and motivated people to join our team. If you are looking for a career that is both challenging and rewarding, and to work for a company at the forefront of the aesthetic industry, please check out our available opportunities. We look forward to hearing from you!

 

 

Essential Duties and Responsibilities

The Sr. Risk Management Specialist is responsible for managing activities related to product safety surveillance and risk management. Serves as a liaison between Quality, Medical Affairs, Clinical Affairs, Research & Development, and Complaint Handling to ensure risk management lifecycle from pre-production Risk Management (RM) to Post Market Surveillance (PMS) processes are executed end-to-end. Reviews and prepares reports on aggregate data and provides recommendation for further escalation. Reviews risk management plans; product, process, and use-related risk analyses (including FMEAs); complaint trend analysis, CAPAs and non-conformances; clinical evaluation reports; risk management reports. Assists in benchmarking best practices with world-class organizations and provides input to establish metrics. The RM specialist has relevant medical device industry experience. This position description identifies the essential functions of this job.

 

 

Additional Duties and Responsibilities

 

Supervisory Responsibilities

None

 

 

Requirements (Education, Certificates, Licenses, Registrations, etc.)

 

Language Skills

Ability to read, analyze and interpret technical procedures or governmental regulations. Ability to write reports or business correspondence.

 

 

Computer Skills

Ability to use word processing, spreadsheet and database applications. Ability to learn various software programs.  Ability to work with data processing and programming.

 

 

Physical Demands and Work Environment

The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

While performing the duties of the job, the employee is regularly required to sit, talk and hear, lift and/or move up to 10 pounds, stand, walk, climb or balance in conditions that include stairs, uneven ground, walking between buildings, etc. Normal vision is required for this job (with corrective lenses if necessary). The work environment is somewhat quiet.

 

 

Travel

Occasional overnight domestic and international travel required, based on need.

 

 

 

This description contains the essential functions necessary to evaluate the position. It is not intended and should not be used as an exhaustive list of all responsibilities, skills or efforts.

 

FLSA Status: Exempt

 

 

If you would like to apply for this position, please email your resume to careers@sientra.com.