Complaint Specialist - #156690
Date: 02/23/2021 21:00 PM
City: Fremont, California
Contract type: Full Time
Work schedule: Full Day
THINK Surgical, Inc. develops, manufactures and markets the only active robotic surgical systems for orthopedic surgery. The systems include two components: a 3D workstation for preoperative planning, and a computer assisted tool utilized for cavity and surface preparation for hip and knee replacement surgeries. The systems have been used in thousands of joint replacements worldwide.
Performs activities within the overall post market surveillance program at THINK Surgical, including and processing of product feedback and complaints as well evaluation of events in compliance with 21 CFR, 820, ISO 13485 as well as other applicable US and OUS regulations. Interface with cross-functional departments
DUTIES & RESPONSIBILITIES
- Processing of the product feedback and complaint handling process in compliance with applicable US and OUS regulations.
- Participate in cross-functional meetings to review complaints and other post market data.
- Ensure post market feedback including complaints is processed, investigated and closed in a uniform and timely manner. This will include receiving complaints, initiating complaint files, performing and documenting complaint investigations, and taking appropriate actions to close the complaint files.
- Evaluate documentation for completeness and consistency and assign additional actions as necessary to close the complaint file. Approve final complaint file for closure after all applicable actions are completed. Manage complaint workload to required backlog goals. Review and analyze lot documentation (DHRs) to determine if there are any anomalies that maybe related to reported product failures.
- Interface with Customer Service team and hospitals including retrieval of RMA to obtain information regarding product feedback and complaints.
- Create customer response letters. Provide peer review and feedback of complaints and reports.
- Perform/support regulatory reporting determination for complaints submissions.
- Interface with the cross functional teams and external agencies as needed for the regulatory reporting decision and submissions.
- Prepare customer communication (response letters, acknowledgement letters) as appropriate.
- Compile and provide metrics on post market data for Management Review.
- Implement and maintain electronic complaint management and reporting systems (eMDR) in compliance with FDA regulations.
- Conduct training for post market feedback and complaint handling processes.
- Support continuous improvement and corrective and preventive action when necessary to address timeliness, efficiency, and overall compliance of post market processes.
- Maintain knowledge of applicable external standards, applicable regulations and requirements, and implement new requirement into related procedures.
- Support Risk Management activities related to complaint handling and post market surveillance.
- Participate in internal audits as assigned, in accordance with approved audit schedule.Support company goals and objectives, policies and procedures, FDA and OUS regulations.
- Perform other duties as necessary.
- Bachelor’s degree (or equivalent experience) with 3-5 years of related experience
- A minimum of 3 years of combined experience in post market surveillance, complaint management, event reporting and the knowledge of regulations associated with these functions is required.
- Ability to manage priorities and workflow in a rapidly changing environment
- Excellent organizational, problem-solving, and analytical skills
- Excellent communications, documentation and time management skills required.
- Must be able to work with minimal supervision.
- Good interpersonal skills
- Participate with internal/ISO/FDAquality audits
- Experience with medical instrumentation and disposables, in a regulatory environment
- Working knowledge of basic quality systems regulations such as QSR and ISO.
- Proficient technical writing skills and use of documentation programs (Example Office Windows, Excel, Access, Power Point, etc.).
- Working knowledge of fundamental quality and statistical tools
- Possess excellent interpersonal and communication skills with the ability to develop trust, respect and confidence with internal and external customers.
- Knowledge of good manufacturing practices (GMP) and applicable Quality System Standards.
- Attendance and Punctuality are essential function of the position.
- Drives results
- Optimizes work processes
- Decision Quality
PHYSICAL DEMANDS & WORK ENVIRONMENT
- Must be able to remain in a stationary position and operate office equipment for a prolonged period of time.
- Physical activities include, but not limited to constant manual dexterity, moving about the work site, and/or handling objects weighing up to 20 lbs.
- Other infrequent physical activities include, but not limited to, positioning self to complete assigned tasks, and ascending/descending floors and/or ladders.
- Occasionally work around moving mechanical parts.
- Must be able to work in a schedule that commensurate with business operation, including work during weekends, holidays and/or times outside of normal business hours.
- Must be able to travel as business necessitates (up to 10 % Travel).
THINK offers a fast-paced, dynamic environment with the advancement potential of an entrepreneurial company. We provide a competitive compensation package that includes comprehensive benefits, a company-matched 401k plan, and more. We strive to build the strongest and brightest teams in the industry. If you would like to work on tomorrow’s leading orthopedic solutions today, we would love to hear from you.
THINK is an equal opportunity employer that hires a diverse workforce. All qualified applicants will receive consideration for employment without regard to their race, color, national origin, religion, age, sex, disabilities, veteran status, or sexual orientation.