Quality Assurance Complaints and Compliance Specialist

Tosoh Bioscience, Inc.•Grove City, OH

4d•Onsite

About The Position

Under the direction of Technical Support Management, the Quality Assurance Complaints and Compliance Specialist provides quality assurance and regulatory affairs support for complaints handling and compliance reporting within the Tosoh Bioscience, Inc. Quality System. The role supports compliance with FDA Code of Federal Regulations (21 CFR 820), ISO 13485, and company policies and procedures. The specialist leads accurate and timely compliance reporting, evaluates technical service enquiries and complaints, maintains compliance records, and prepares reports in collaboration with Technical Support Services and Quality Assurance & Regulatory Affairs management. The position also supports regulatory submissions and audits, training program development, and departmental metrics and trending. The role is based in Grove City, Ohio, during standard business hours and may require visits to customer medical facilities. Site access may depend on meeting customer screening, immunization, and vendor credentialing requirements.

Requirements

Bachelor’s degree in a biological science-related field.
At least 3 years of experience in complaints handling and compliance reporting in the IVDD, clinical diagnostics, or medical device industry.
In-depth understanding of FDA 21 CFR Complaints: 820.198; ISO 13485 Improvement (Section 8.5.1); and MDR requirements (FDA 21 CFR 803.17 and 803.50(a)(1)).
Strong investigative and problem-solving skills.
Ability to communicate Quality System requirements and manage compliance with them.
Ability to work across functional teams within the organization.
Strong attention to detail and timeliness.
Excellent verbal, written, and interpersonal communication skills.
Ability to meet customer facility access requirements, which may include drug, background, and health screening; providing or obtaining required immunizations; and registering through vendor credentialing, as applicable.

Nice To Haves

Master’s degree in Biomedical Engineering preferred.
Root cause analysis techniques.
Familiarity with basic statistical methods, including trend analysis, Pareto analysis, and other basic charting techniques.

Responsibilities

Lead accurate and timely compliance reporting in accordance with ISO 13485 and FDA Quality System Regulations.
Review and evaluate technical service enquiries and complaints for validity and accuracy.
Manage and update TSS Tickets, and collaborate with TSS team members.
Review and maintain compliance files, ensuring required reviews and approvals are completed within specified timeframes.
Record, document, and post minutes for compliance team meetings.
Compile, prepare, review, and manage Complaint, eMDR, NCR, CAPA, SCAPA, and Recall reports in collaboration with Technical Support Services and Quality Assurance & Regulatory Affairs management.
Support validation activities related to compliance reporting in accordance with current regulatory requirements.
Serve as a lead Core Team Member to establish a training program for Compliance Reporting.
Ensure compliance reports are entered into the quality record in collaboration with stakeholder departments.
Submit MDRs and Recall advisories according to FDA requirements, ensure follow-up activities are completed, and communicate them to the manufacturer as required.
Complete compliance reports required by applicable federal, state, and local regulatory agencies.
Participate in internal and external regulatory audits concerning TSS and Compliance Reporting.
Design and establish training and training programs for complaint handling and compliance.
Establish and maintain departmental metrics and trending.