Mindlance · 3 weeks ago
Quality Assurance Analyst I_US
Princeton, NJ
Full-time
Hybrid
Entry Level
2+ years expMindlance is a company specializing in staffing and consulting services, and they are seeking a Quality Assurance Analyst I to join their team. The role involves reviewing and assessing complaint records in accordance with regulatory requirements, providing feedback to ensure compliance, and driving continuous improvement in complaint handling processes.
Human Resources
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
Qualification
Required
2+ years experience with complaints in med device, pharma background
regulated industry experience may be ok
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
Mindlance
Mindlance is a Staffing and Recruiting company which provides multi-vertical staffing services
1001-5000 employees
H1B Sponsorship
Mindlance 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 (71)
2024 (53)
2023 (37)
2022 (72)
2021 (36)
2020 (40)
Funding
Current Stage
Late StageLeadership Team
R
Rajat Paul Dhall
Co-Founder & Managing Director
V
Vik Kalra
Co-Founder and Managing Director
Recent News
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