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Aditi Consulting · 2 days ago

Quality Assurance Analyst

Princeton, NJ

Contract

Hybrid

Entry, Mid Level

$44.10/hr - $46.10/hr

2+ years exp

Aditi Consulting is seeking a Quality Assurance Analyst to ensure compliance and quality in complaint handling for medical devices and pharmaceuticals. The role involves reviewing complaint records, providing feedback, and collaborating with teams to improve processes.

AppsConsultingInformation TechnologySoftware Engineering

Growth Opportunities

H1B Sponsor Likely

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

Quality ReviewerRegulated industry experienceAnalytical skillsContinuous improvement initiativesDocumentation reviewCoachingWritten communicationVerbal communicationMentoringOrganizational skills

Required

Quality Reviewer

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

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

Preferred

Regulated industry experience may be ok

Benefits

Medical, dental, and vision benefits

Health savings accounts with qualified medical plan enrollment

10 paid days off

3 days paid bereavement leave

401(k) plan participation with employer match

Life and disability insurance

Commuter benefits

Dependent care flexible spending account

Accident insurance

Critical illness insurance

Hospital indemnity insurance

Accommodations and reimbursement for work travel

Discretionary performance or recognition bonus

Sick leave and mobile phone reimbursement provided based on state or local law.

Company

Aditi Consulting

Glassdoor4.2

Aditi Consulting is a firm that stays abreast of offering technological solutions, project management and digital transformation.

Founded in 1994

Bellevue, Washington, USA

1001-5000 employees

https://aditiconsulting.com

H1B Sponsorship

Aditi Consulting 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 (55)

2024 (44)

2023 (25)

2022 (26)

2021 (24)

2020 (30)