Quality Assurance Manager

ClinLab Staffing; Monroe (NJ); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Medical insurance

Vision insurance

401(k)

Job summary

A staffing company specializing in quality assurance recruitment seeks an experienced Quality Assurance professional in Monroe, NJ. You will oversee audit readiness, manage Corrective Actions, and ensure compliance with ISO 13485 standards. The ideal candidate needs a Bachelor’s degree in Biomedical Engineering or related fields and at least 5 years in QA. Competitive salary range of $80,000 to $100,000 per year. This full-time role offers opportunities for professional growth in a dynamic environment.

Qualifications

• Experienced Quality Assurance professional with 5-7 years in the medical device industry.
• Minimum of 5–7 years experience in Quality Assurance within the medical device or pharmaceutical industry.

Responsibilities

• Prepare and maintain the quality system in a state of audit readiness.
• Lead internal preparation and documentation support for regulatory, customer, and certification audits.
• Respond to auditor inquiries and ensure timely resolution of findings.
• Manage the full lifecycle of Corrective and Preventive Actions.
• Ensure proper planning and protocol development are in compliance with regulatory requirements.

Job description

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This range is provided by ClinLab Staffing. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$80,000.00/yr - $100,000.00/yr

Direct message the job poster from ClinLab Staffing

Scientific Recruiter focusing in NY, NJ, PA, MD, and DE

Position Summary

Experienced Quality Assurance professional with 5-7 years in the medical device industry, focused on audit response, CAPA, validation, and document control within ISO 13485-compliant environments.

Duties & Responsibilities

• Prepare and maintain the quality system in a state of audit readiness.
• Lead internal preparation and documentation support for regulatory, customer, and certification audits (e.g., ISO 13485/cGMP/MDSAP/IVDR/WHO PQ).
• Respond to auditor inquiries and ensure timely resolution of findings.
• Manage the full lifecycle of Corrective and Preventive Actions (CAPA), including root cause analysis, implementation of corrective actions, effectiveness checks, and documentation.
• Collaborate with cross-functional teams to ensure long-term compliance and quality improvements.
• Lead and coordinate equipment, process, and software validation activities.
• Ensure proper planning, protocol development, execution, deviation handling, and reporting are in compliance with regulatory requirements and internal procedures.
• Oversee creation, revision, approval, and archiving of controlled documents including SOPs, work instructions, forms, and quality records.
• Ensure alignment with document control policies and support training on new or revised procedures.
• Support the implementation and monitoring of QMS elements (ISO 13485).
• Lead quality initiatives and gap assessments, and drive continuous improvement through internal audits, KPI monitoring, and quality review meetings.

Qualifications

• Bachelor's degree in Biomedical Engineering, Biotechnology, or a related field in life sciences or engineering
• Minimum of 5–7 years experience in Quality Assurance within the medical device or pharmaceutical industry, including audit preparation, nonconformance handling, and quality system maintenance

Knowledge, Skills, and Abilities

• ISO 13485 Internal Auditor certification (preferred)
• RCC-MDR or equivalent regulatory training (preferred)
• English and Korean bilingual (preferred)
• In-depth understanding of ISO 13485 and QMS requirements
• Experience with CAPA systems, validation protocols (IQ/OQ/PQ), and document control procedures
• Strong attention to detail
• Problem-solving mindset
• Effective communication and documentation skills
• Ability to work in cross-functional teams

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Biotechnology Research, Medical Equipment Manufacturing, and Pharmaceutical Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

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