Career Opportunities

Position: Department: Location:

Complaint Management Specialist Quality Assurance Remote

 

 

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

Complaint Management Specialist is responsible for evaluating, processing, and investigating Sientra product complaints and responding to product related inquiries. This position interacts with various complaint and product inquiry sources, including Sientra Plastic Surgery Consultants, physicians and other health-care professionals, internal customer/sales experience and warranty claim personnel, and other company personnel to collect relevant information and facilitate the resolution of reported product issues and concerns in a timely and efficient manner.

 

 

Additional Duties and Responsibilities

• Monitoring the Device Retrieval Data Base (DRDB) and working with personnel at independent lab to ensure returned/explanted devices are received and analyzed in a timely manner.
• Compiling complaint information, device history information, and device analysis data to complete complaint investigations and process the closure of complaints in automated complaint management system in a timely manner.
• Review complaints to determine FDA and International regulatory reporting requirements and create reports to comply with reporting requirements as necessary.
• Compiling complaint information, device history information, and device analysis data to complete complaint investigations and process the closure of complaints in complaint management system in a timely manner.
• Review complaints and decision trees to determine FDA and International regulatory reporting requirements and create reports to comply with reporting requirements as necessary
• Responsible for data input and maintenance of Sientra’s complaint management system according to established requirements and for facilitating ongoing improvement and investigation of complaint records.
• Answer technical and medical related questions to aid in accurate and prompt assessment of product complaints
• Collaborate with product support team to facilitate the timely completion of complaint investigation tasks
• Understand and comply with all regulatory, quality, safety, and environmental practices and procedures as outlined in organizational/departmental guidelines and SOPs, external regulations as well as applicable federal, state and local regulations.
• Interface with the Customer Success and Warranty team to facilitate the successful processing of warranty claims.
• Assist QA Device Tracking in resolving data conflicts and acquiring the necessary information to permit Warranty activation for patients enrolled in Sientra’s warranty programs.
• Provide accurate data input into complaint, CAPAs, NCMRs, FMEAs and other Sientra documentation systems as required.
• Facilitate the development and presentation of regulatory and compliance requirements
• relating to Product Support and Device Tracking to company staff and management.
• Assist in internal audits as needed, working with internal staff and consultants.
• Provide assistance in compiling data for scheduled management reviews.
• Other duties as assigned

 

Supervisory Responsibilities

This job has no supervisory responsibilities.

 

 

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

• B.S. degree; 4+ years of experience in quality of manufacturing role; or equivalent combination of education and experience
• Manufacturing, medical device or highly regulated experience preferred
• Excellent written and verbal communication and interpersonal skills.
• Strong analytical skills with a high level of proficiency using Excel and performing analysis
• Independent thinking, problem solver, detailed (but sees the big picture), conscientious, diligent, flexible, able to prioritize, reliable, remains calm under tight deadlines.
• Must possess a valid driver’s license

 

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.

 

 

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.

 

 

 

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: Non-Exempt

 

 

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