TSI Group · 4 hours ago
Quality Assurance Supervisor
United States
Full-time
Remote
Senior Level
5+ years expTSI Group is a company focused on maintaining high standards of product quality. They are seeking a Quality Assurance Supervisor to lead post-market quality service activities and ensure compliance with quality standards at their JV manufacturing facility.
Health CareManufacturing
Responsibilities
Customer Complaint Management: Lead the investigation and resolution of complex customer complaints, ensuring thorough root cause analysis, timely closure, and effective CAPA implementation
Quality Documentation: Serve as the central point for providing and managing all product quality documentation requested by customers, regulatory bodies, and sales/marketing teams (e.g., Certificates of Analysis, Product Specifications, Batch Records)
Quality Risk Management (QRM): Facilitate and document risk assessments for product quality trends, process changes, and post-market surveillance data
Product Quality Reviews: Compile and analyze data for annual product quality reviews, identifying trends and recommending continuous improvement actions
Supplier Quality Support: Interface with the Supplier Quality team to address raw material-related issues that surface in the market, providing data and feedback from customer complaints
Primary Quality Liaison: Act as the main quality coordination point between US TSI and InnoPak & ACB's quality and operations management team
Quality Plan Coordination: Partner with the ACB & JV plant to ensure the successful implementation and adherence to TSI global quality plans, policies, and procedures. Track and report on progress
On-Site Presence & Monitoring: Conduct scheduled on-site visits to the JV plant (e.g., quarterly or as defined by risk) to monitor GMP compliance, observe operations, and perform process confirmation audits. Report findings to management
Issue Escalation & Communication: Facilitate clear and timely communication of quality issues between the JV plant and corporate leadership. Ensure critical issues are escalated appropriately and addressed through the corporate quality system
Audit Readiness: Assist the JV plant in preparing for corporate audits and regulatory inspections (FDA). Participate in audit response and CAPA verification as needed
The other objectives assigned by Line manager
Qualification
Required
Bachelor's degree in Chemistry, Microbiology, Food Science, Engineering, or a related scientific field
Minimum of 5 - 7 years of experience in a Quality Assurance role within the FDA-regulated industry
At least 2 years in the dietary supplement (21 CFR 111) or pharmaceutical sector
Familiarity with commercial QA system
Excellent communication skills
Deep understanding of FDA cGMP (21 CFR Part 111), NSF GMP and FSSC22000
Company
TSI Group
Lead the Supplement Industry Revolution — Join TSI in Building a Healthier Future Why Now? TSI Group has just reached a defining milestone — our successful listing on the Shanghai Stock Exchange Main Board (JYJT: 603262).
501-1000 employees
H1B Sponsorship
TSI Group has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (2)
2023 (3)
2022 (1)
2021 (1)
2020 (3)
Funding
Current Stage
Late StageLeadership Team
J
Joe Zhou
CEO
D
David LV
Executive Assistant to CEO / BD
Company data provided by crunchbase