Quality Assurance Analyst I - (VB2025)

Job Description

Job Description

This position is set for 6+ Months Contract that is only on W2. (No C2C, No C2H and no 1099)

We require 2+ years experience with complaints in med device, pharma background.

Key Responsibilities
• Review and assess the accuracy, completeness, and compliance of all complaint records (including parent and child records) in accordance with internal procedures and regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485, MDR).
• Provide clear, actionable quality feedback to complaint owners and investigators to ensure high-quality documentation and adherence to quality system standards.
• Verify that all complaint files undergo Internal Quality Review and are completed, approved, and closed within defined timelines.
• Confirm that investigation records accurately document the root cause analysis, corrective actions, and justification for closure.
• Facilitate stakeholder meetings when necessary to clarify complaint details, investigation expectations, or closure requirements.
• Ensure complaint files are audit-ready and capable of standing alone during internal, external, or regulatory audits.
• Identify trends, process gaps, and recurring issues, and collaborate with cross-functional teams to drive continuous improvement in complaint handling and closure processes.

Skills and Competencies
• Strong analytical skills with attention to detail and accuracy in documentation review.
• Excellent written and verbal communication skills for effective collaboration with global and cross-functional teams.
• Demonstrated ability to coach, mentor, and train team members to improve complaint quality and compliance.
• Proven ability to organize, prioritize, and manage multiple complaint records to meet closure timelines.
• Experience in identifying and implementing continuous improvement initiatives within a regulated quality system environment.

Company DescriptionTechLink Systems is a national provider of staffing services with offices all over the USA as well as development and support centers globally. We are a MBE (NMSDC), WBE (WBENC), and WOSB certified minority business that has been awarded 2017 TAPFIN Premier Partner, 2016 Manpower Excellence Award, 2016 TAPFIN Elite Partner, are a Known Tier Supplier for Agile 1, and have been ranked as a Top Women and Minority Owned Company since 2004 by several businesses including Philadelphia Business Journal, Diversity Business, Inc 5000, Inc 500, San Francisco Business Times, Diversity2000, and Los Angeles Business Journal.

We serve the contract staffing, direct hire, staff augmentation, recruitment, HR management, and project outsourcing needs of clients nationwide. Striving to create personal relationships with clients, TechLink Systems becomes a virtual extension of clients’ own in-house capabilities to help achieve new levels of growth, productivity, and competitiveness.

We also have national recruiting

Company Description

TechLink Systems is a national provider of staffing services with offices all over the USA as well as development and support centers globally. We are a MBE (NMSDC), WBE (WBENC), and WOSB certified minority business that has been awarded 2017 TAPFIN Premier Partner, 2016 Manpower Excellence Award, 2016 TAPFIN Elite Partner, are a Known Tier Supplier for Agile 1, and have been ranked as a Top Women and Minority Owned Company since 2004 by several businesses including Philadelphia Business Journal, Diversity Business, Inc 5000, Inc 500, San Francisco Business Times, Diversity2000, and Los Angeles Business Journal. \r\n\r\nWe serve the contract staffing, direct hire, staff augmentation, recruitment, HR management, and project outsourcing needs of clients nationwide. Striving to create personal relationships with clients, TechLink Systems becomes a virtual extension of clients’ own in-house capabilities to help achieve new levels of growth, productivity, and competitiveness. \r\n\r\nWe also have national recruiting