Quality Assurance Complaints and Compliance Specialist

Tosoh Bioscience, Inc.; Grove City (OH); Presencial; USD 75.000 - 110.000; Jornada completa

Descripción de la vacante

Tosoh Bioscience, Inc. in Grove City, OH is seeking a Compliance/QA specialist to manage complaints, drive regulatory reporting, and support audits. You will coordinate across technical support, field service, and QA/RA teams to ensure accurate ticketing and timely MDR/MDV submissions.

The role requires deep knowledge of FDA 21 CFR 820, ISO 13485, and multiple regulatory regimes, with a track record in medical device complaint investigations and cross-functional collaboration.

Formación

• Bachelor Degree in a biological science-related field.
• Biomedical Engineering Masters Degree preferred.
• Deep understanding of FDA 21 CFR 820.198 and ISO 13485.
• Minimum 3 years' complaints handling and regulatory reporting experience.
• Strong investigative and problem-solving skills.
• Ability to work across functional teams.
• Excellent written and verbal communication.

Responsabilidades

• Manages and updates tickets associated with complaints.
• Collaborates with technical support, field service, and SMEs to ensure complete records.
• Maintains and summarizes the complaints database and closed investigations.
• Leads investigation efforts in systems instrumentation and reagents.
• Analyzes events to determine status and regulatory reportability (ISO, Health Canada, ANVISA, FDA).
• Compiles and submits MDR/MDV documentation with QA & RA teams.
• Ensures timely MDR/MDV reporting for ex-US geographies.
• Participates in audits and regulatory inspections as required.
• Designs and delivers training for complaint handling and compliance.
• Establishes departmental metrics and trending.

Conocimientos

Investigation

Problem solving

Root cause analysis

Communication

Statistics

Attention to detail

Cross-functional

Educación

Bachelor in biological sciences

Biomedical Engineering Masters

Descripción del empleo

Tosoh Bioscience, Inc., based in Grove City, Ohio is a U.S. subsidiary of Tosoh Corporation's Bioscience Division, headquartered in Tokyo, Japan. Established in the United States in 1989, Tosoh Bioscience has become known throughout the Americas for providing sophisticated diagnostic systems to doctor's offices, hospitals and reference laboratories. Tosoh remains at the forefront with a world class network of research facilities, scientists, engineers and customer support specialists.Summary:Under the direction of the Complaints Manager, performs critical Quality Assurance and Regulatory Affairs Complaints Handling and Compliance Reporting support for the Tosoh Bioscience, Inc. Quality System in compliance with FDA Code of Federal Regulations (21 CFR 820), ISO 13485, and Tosoh Bioscience, Inc. (TBI) Policies and Procedures.Main Duties and Responsibilities:Manages and updates Tickets associated with complaints.Collaborate with Technical Support Specialists, Field Service Engineers, Clinical Support Specialist, Customers or Subject Matter Experts to ensure required information is recorded in the tickets / complaints records.Maintains the complaints database updated as soon as factual information is available and summarize closed investigations into the database accurately.Reviews and evaluates technical services inquiries and complaints to ensure accuracy, and completeness of information;Leads complaint investigation efforts in area of Systems instrumentation and reagents.Analyzes events reported from multiple inputs to determine complaint status and regulatory reportability, (ISO, Health Canada, ANVISA) and FDA Quality System Regulations).Compiles, reviews, escalates, and submits documentation for complaint, eMDR, CAPA, SCAR, & Recall) in close collaboration with Technical Support Services and Quality Assurance & Regulatory Affairs management.Ensures timely Medical Device Reports (MDR), Medical Device Vigilance (MDV), and additional reporting per regulatory reporting in EX-US geographies where Tosoh products are distributed.Participates in external and internal regulatory audits as required for matters related to TSS, Complaints, Regulatory Reporting, and Corrections & Removals.FDA/Regulatory Responsibilities:Submits MDRs and Recall advisories according to FDA requirements and ensure that all follow-up activities are completed and are communicated to manufacturer as required.Completes required compliance reports as required by applicable federal, state and local regulatory agencies.Participates in external and internal regulatory audits as required for matters related to TSS & Compliance Reporting.Training: Design and Establish training and training programs for complaint handling and compliance.Trending: Establish and maintain departmental Metrics and Trending.Qualifications:Educational Background: Bachelor Degree in a biological science-related field. Biomedical Engineering Masters Degree preferred.Requires in depth understanding of FDA 21 CFR Complaints: 820.198 & ISO 13485: Improvement (Sec. 8.5.1) MDR (FDA 21 CFR 803.17 & 803.50(a)(1)) is required with a minimum of 3 years experience in complaints handling and compliance reporting in the field of IVDD, clinical diagnostics, and medical device industry.Strong investigational and problem solving skills. Root cause analysis techniques a plus.The ability to communicate Quality System requirements and manage compliance of same is expected.Must work across functional teams within the organizationAttention to detail and timeliness are critical and a mustExcellent communication (verbal and written) and interpersonal skills requiredBasic statistical methods including trend analysis, pareto, and other basic charting techniques is a plus.Working Conditions:This position may require visits to customer sites which are medical facilities. These facilities may have certain requirements which TBI 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.TBI is an Equal Opportunity Employer M/F/Disabled/Veterans