Shoolin Inc

Shoolin Inc is a staffing and technology solutions company specializing in tailored talent acquisition and recruitment excellence across Science, Engineering, Technology, Clinical & Life Sciences,…

EngineeringLife SciencesPharmaceuticalRecruitmentScienceStaffingTalent AcquisitionTechnology Solutionsshoolin-inc.com

Shoolin Inc

Shoolin Inc is a staffing and technology solutions company specializing in tailored talent acquisition and recruitment excellence across Science, Engineering, Technology, Clinical & Life Sciences,…

EngineeringLife SciencesPharmaceuticalRecruitmentScienceStaffingTalent AcquisitionTechnology Solutionsshoolin-inc.com

HQIselin, US

Team Size60

Open Jobs21

Total Funding-

Latest FundraiseUnknown

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We are seeking a highly experienced Internal Auditor to support QMS remediation initiatives for a Class III medical device portfolio . This is a high-visibility, execution-focused role requiring deep expertise in Design Controls, Risk Management, and QMS effectiveness .

Location: Wayne, NJ (Hybrid – 4 days onsite, 1 day remote)

Duration: Through end of 2026

Key Responsibilities:

Required Qualifications:

Preferred:

Experience with ISO 14971 (Risk Management)
Experience supporting post-audit remediation programs
Tools: TrackWise (QMS), Jama (ALM/Design Controls)

Plan, execute, and document internal quality audits for remediation and inspection readiness

Perform deep-dive audits across CAPA, Complaints, Design Controls, Risk Management, Change Control, Supplier Quality

Assess QMS effectiveness (beyond procedural compliance)

Identify systemic gaps , perform root cause analysis , and support CAPA development

Collaborate with Quality, Engineering, and Regulatory teams

Ensure audit deliverables are clear, defensible, and inspection-ready

Track remediation activities and perform effectiveness checks

Operate independently in a fast-paced remediation environment

10+ years of Quality experience in regulated manufacturing environments

Strong experience with Class III Medical Devices

Extensive hands-on experience in internal audits (QMS remediation/compliance)

Deep expertise and certifications in:

FDA QMSR / 21 CFR 820

Strong understanding of:

Risk Management principles

QMS structure & system effectiveness