CAPA & Complaints Analyst

Position Summary

The CAPA & Complaints Analyst is responsible for ensuring day to day Quality oversight to ensure compliance and company engagement with Occurrence Management Systems: Complaints, Quality Events, Deviations, Nonconforming Product, and Corrective Actions & Preventive Actions (CAPA). This role is specifically resourced to and responsible for Complaint Handling. The CAPA & Complaints Analyst may also collaborate on evaluation of Nonconforming Product, Nonconforming Materials, and engage with Internal and External Audits, Quality Planning, and other Quality Management System functions as needed. Individual will work closely with cross-functional resources across Caris Life Sciences and Caris’ external customers. This position focuses on global Quality Systems and Regulatory support for Complaints, Quality Events, Deviations, and Corrective Actions & Preventive Actions (CAPA) for in vitro diagnostic devices. This role will provide technical and administrative Quality oversight for Complaints in all Domestic and International regions, including record coding for USA, EU, China, Japan, Latin America, Australia, and closing files appropriately within timeframe defined by procedure.

Job Responsibilities

• Ensure compliance with the company's Quality System policies and procedures, as well as applicable external requirements and standards, including FDA (21 CFR), ISO 13485, CMDCAS, PMDA, CAP/CLIA, New York State and other national and/or worldwide regulatory agencies, Health & Safety Practices, and other applicable standards as pertaining to medical devices.
• Liaise with relevant functional groups, facilitate, and mentor teams through all stages of Complaints Handling and associated processes.
• Review reportable and potentially reportable complaints and other Occurrence Management records for reportability.
• Evaluate all information from a clinical and technical perspective to ensure appropriate investigation and correction/resolution is documented prior to record closure. Responsible for review and approval of Occurrence Management records, acting as the Subject Matter Expert for Complaints to ensure completeness, accuracy, effectivity, and timeliness along with the review and approval of record updates, changes, and extension requests.
• Participate and assist with ensuring adequate training is maintained and provided to all users of Occurrence Management process and systems, with specific ownership of the company-wide Complaint training program.
• Act as a Subject Matter Expert (SME) and ensuring compliance to all related Quality and Regulatory related procedures such as, but not limited to, Complaint Handling, Medical Device Reporting (MDR), and Post Mark Surveillance (PMS).
• Ensure accurate documentation of evaluation and investigation result of the Occurrence Management files; including literature files, and clinical files.
• Responsible to assess and review additional information and make MDR determination based on the additional information received. Interact with Manufacturing site by requesting DHR when lot is provided (Device History Record).
• Assist with the summary reporting for the US FDA, CAP/CLIA and other Regulators as certified. Responsible for updating files with new information, assess that new information to determine what needs immediate attention, malfunction reporting, regulatory reporting and assisting with the final review of a triage of files before the case can be closed.
• Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
• Other duties as assigned.
  
  

Required Qualifications

• Bachelor's degree in related scientific field.
• 3-5 years of professional quality experience with Medical Devices, Clinical Laboratories, IVDs, or related field.
• 1 year experience dealing with basic principles, theories, concepts, and techniques related to Quality Systems, Occurrence Management, specifically Complaint Handling.
• Proficient in Microsoft Office Suite, specifically Word, Excel, Outlook, and general working knowledge of Internet for business use.
  
  

Preferred Qualifications

• Demonstrated success independently working with cross-functional teams.
• Strong Communication, interpersonal and problem-solving skills, and detail oriented.
• Drive for Results (Service, Quality, and Continuous Improvement) – Ensure procedures and processes are in place that lead to delivery of quality results and continually reassess their effectiveness to achieve continuous improvement.
  
  

Physical Demands

• Employee may be required to lift routine office supplies and use standard office equipment.
• Ability to sit for extended periods of time.
• Majority of work is performed in a desk/cubicle environment, but at times, may have exposure to high noise levels in the data center, fumes, and bio-hazardous material in the lab environment.
  
  

Training

• All job specific, safety, and compliance training are assigned based on the job functions associated with this employee.
  
  

Other

• This position may require periodic travel and some evenings, weekends and/or holidays.
  
  

Conditions of Employment: Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check ( applicable for certain positions) and reference verification.

This job description reflects management’s assignment of essential functions. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

Caris Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with disability.