Quality Assurance Manager

Get AI-powered advice on this job and more exclusive features. 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 57 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 ClinLab 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. 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