Quality Assurance Manager

Get AI-powered advice on this job and more exclusive features.

This range is provided by Clin Lab 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 - $/yr

Direct message the job poster from Clin Lab 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

Referrals increase your chances of interviewing at Clin Lab Staffing by 2x

Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Get notified about new Quality Assurance Manager jobs in Monroe, NJ.

East Windsor, NJ $-$ 4 months ago

Cranbury, NJ $-$ 22 hours ago

Cranford, NJ $-$ 1 month ago

Manager, Customer Service and Quality Assurance

Somerville, NJ $-$ 6 days ago

Environmental Quality Assurance/Quality Control Manager (Tech Law)

North Brunswick, NJ $-$ 1 week ago

Food Safety and Quality Assurance Manager

Linden, NJ $-$ 1 week ago

Bridgewater, NJ $-$ 3 weeks ago

New Brunswick, NJ $70,920.00-$ 3 months ago

Manager, Pharmacovigilance Quality Assurance

Bridgewater, NJ $-$ 2 weeks ago

Manager, Pharmacovigilance Quality Assurance Program Manager (Cancer Surveillance Operations) (Trenton, NJ)
Assurance Manager, Quality Management - IS Assurance

Woodbridge, NJ $-$ 2 weeks ago

Johnson & Johnson, Licensing & Acquisition R&D Quality Manager - Application via Way Up

Somerville, NJ $-$ 9 hours ago

Johnson & Johnson, Licensing & Acquisition R&D Quality Manager - Application via Way Up

Titusville, NJ $-$ 9 hours ago

New Jersey, United States $70,000.00-$ 1 month ago

Registered Nurse - Quality Assurance Coordinator

Long Branch, NJ $70,920.00-$ 2 weeks ago

Johnson & Johnson, Licensing & Acquisition R&D Quality Manager - Application via Way Up

New Brunswick, NJ $-$ 15 hours ago

Manager, Quality Assurance, Veterans Village, Homeless Veteran Program Licensing & Acquisition R&D Quality Manager

Titusville, NJ $-$ 1 week ago

Licensing & Acquisition R&D Quality Manager

Somerville, NJ $-$ 1 week ago

Licensing & Acquisition R&D Quality Manager

New Brunswick, NJ $-$ 1 week ago

Cranford, NJ $95,000.00-$ 2 weeks ago

Cranford, NJ $95,000.00-$ 5 days ago

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

#J-18808-Ljbffr