Senior Quality Assurance Complaints Compliance Specialist

Description

Tosoh Bioscience, Inc., based in South San Francisco, CA 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 Complaint Handling & Compliance Manager, performs critical Quality Assurance and Regulatory Affairs Complaints Handling 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.

Reporting Relationships

• None

Major Duties and Responsibilities

ISO 13485 Responsibilities:

• Serves as the lead to ensure accurate and timely compliance reporting in accordance with ISO 13485 and FDA Quality System Regulations.

• Review and evaluate technical services enquiries and complaints for validity and accuracy,

• Manage and update TSS Tickets.

• Collaborate with TSS team members.

• Review and maintain compliance files and ensure review and approvals have been obtained within timeframes outlined.

• Compile, Prepare, Review, and Manage compliance reports (Complaint, eMDR, NCR, CAPA, SCAPA, & Recall) in close collaboration with Technical Support Services and Quality Assurance & Regulatory Affairs management.

• Support validation activities associated with Compliance reporting in accordance with current regulatory requirements.

• Serves as lead Core Team Member to establish training program for Compliance Reporting.

• Ensures that compliance reports are entered into the quality record in close collaboration with all stakeholder departments.

FDA/Regulatory Responsibilities:

• Submit MDRs and Recall advisories according to FDA requirements and ensure that all follow-up activities are completed and are communicated to manufacturer as required

• Complete 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 Master’s 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 organization

• Attention to detail and timeliness are critical and a must

• Excellent communication (verbal and written) and interpersonal skills required

• Basic 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 Requirements

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.

Tosoh Bioscience, Inc. is an Equal Opportunity Employer M/F/Disabled/Veterans

Qualifications