TITLE: Clinical Data Analyst Specialist Must have experience with In Vitro Diagnostics (IVD)SUMMARY: Under the direction of the Manager, Technical Support , supports critical Quality Assurance (QA) and Regulatory Affairs (RA) activities for our Client's. Quality System in compliance with FDA Code of Federal Regulations (21 CFR 820, 803, and 806), ISO 13485, and our Client's Policies and Procedures. This person will handle data request, projects, and tasks, through the QA Complaints and Compliance group and play an active role in the processes to ensure products meet quality standards consistent with both policies, while meeting all applicable regulatory requirements related to safety and quality for medical devices and In-Vitro Diagnostics (IVD). ESSENTIAL DUTIES AND RESPONSIBILITIES: Create, build, and conduct monthly complaint trend analysis reports and quality metrics for the organization s Trending Review Board (TRB) and cross functional teams for management decision making. Develop and monitor quality metrics for complaint handling process and related processes. Responsible for generating and delivering ongoing and ad-hoc reports to internal customers who might require complaint data and information for investigations, CA/PAs etc. Develop and implement data analyses, data collection systems, and other strategies that optimize statistical efficiency and quality compliance. Identify, analyze, and interpret trends or patterns in complex data sets using statistical techniques. Support data analysis for Corrections & Removals Monitor, identify and define / recommend new process improvement opportunities and solutions for compliance, cost saving, and standardization for the organization. Project manager for data-driven process improvement opportunities with Lean focus. Support validation activities associated with software tools used for complaint handling and regulatory reporting in accordance with regulatory requirements. Participate in external and internal regulatory audits as required for matters related to Technical Service, Complaints, Regulatory Reporting, and Corrections & Removals. As needed, coordinate the identification, assignment, monitoring, and completion of process improvement projects in cross-functional teams. Provide guidance and training to internal customers, as related to quality compliance Act as the liaison between internal customers and Complaint / Compliance team regarding complaint data. Support all audit activities. Support MDR filings as needed Other duties as assigned by manager FDA / REGULATORY RESPONSIBILITIES Provide data analysis as requested by FDA, regulatory agencies, notified body, and / or as requested by management Participate in FDA and regulatory agency inspections (e.g. MDSAP, ISO) as required QUALIFICATIONS: Bachelor Degree in a science-related field, engineering / mathematics, business analytics biological science a plus; MBA preferred. ASQ CQPA, CQM, CSSGB, CSSBB a plus An in depth understanding of FDA regulations and ISO standards is required with a minimum of 15 years experience in IVD and medical device industry. Strong knowledge and experience with ISO14971, ISO 13485:2016, 21 CFR Part 820, Part 806, Part 11 (Electronic Signatures) Strong knowledge of and experience with reporting packages CRMs such as Sales Logix. Extensive experience with Excel and Minitab applications including knowledge of statistics methods including Trend Analysis, Pareto, SPC, Pivot tables, data analysis and being a data generalist. Apply sound, systematic, scientific, data-driven problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. The ability to communicate Quality System requirements and manage compliance of same is expected. Must work across functional teams within the organization Attention to detail and timeliness are critical and a must. Excellent communication (verbal and written) and interpersonal skills required; this role will require creating quality reports and presentations for executive management. Must be self-directed and independent thinker. Demonstration of technical, team, and solution leadership through strong communication skills to recommend actionable, data-driven insights. Strong project management skills, PMP certification a plus. Proven use of continuous improvement tools, such as Lean and Six Sigma, including Statistical Analysis Methodologies and Quality tools (SPC, Ishikawa, C&E, etc.). Prefer knowledge and experience with Complaints database compliance, including software V&V and change management activities. Proficient computer skills (MS Office). Fluent in English. Knowledge of Japanese a plus. SUPERVISORY RESPONSIBILITIES INCLUDE: Provide oversight of data requests Prioritize resources work and provide feedback to requestors Coordinate with Lead Technical Support Specialist with ticket assignments Schedule and manage weekly compliance meeting for review of data & assignments TRAVEL RESPONSIBILITIES: Minimal (5 15%) WORKING CONDITIONS: This position may require visits to customer sites which are medical facilities. These facilities may have certain requirements which representatives must meet to gain access, including the requirement for drug, background, and health screening. Employment is contingent on your compliance with the requirements established by each facility, as evidenced by the results of the required screenings. Must agree to provide required immunization records and/or agree to acquire required immunizations in order to gain access to customer sites as required by customers. You may be required to register at vendor credentialing PHYSICAL AND ENVIRONMENTAL DEMANDS: To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and / or ability required to be successful. Additional duties may be assigned in the future as required. Reasonable accommodations may be made for those individuals with disabilities in order to perform the essential functions.
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