Senior Quality Assurance Specialist

SENIOR QUALITY ASSURANCE SPECIALISTANNUAL SALARY COMPENSATION: $100K TO $135KOFFICIAL WORK HOURS: 8:00AM TO 4:00PM OR 9:00AM TO 5:00PMREPORT TO: QA MANAGERLOCATION: ONSITE - BROOKLYN NY / JERSEY CITY, NJ – ESTIMATED MOVE DATE: 7/31/2024--------------------------------------------------------------------------------------------------------------------------------------------Regenlab USA is a leading medical device company committed to delivering innovative and reliable healthcare solutions. We pride ourselves on maintaining the highest standards of quality, safety, and compliance in our products. As we continue to grow, we are seeking a dedicated and detail-oriented Senior Quality Assurance Specialist to join our dynamic team. Position Overview:As a Senior Quality Assurance Specialist, you will play a critical role in ensuring the quality and regulatory compliance of our QMS medical devices. This position involves a range of responsibilities, including managing deviations, conducting internal audits, addressing nonconformities, implementing corrective and preventive actions (CAPAs), overseeing critical suppliers, and handling document revisions via Veeva Vault. Additionally, you will be involved in change control processes and contribute to the preparation of mock batch recall reports. Key Responsibilities:· Deviations: Investigate and manage deviations from established procedures, ensuring timely resolution and documentation.· Internal Audits: Plan, conduct, and report on internal audits to ensure adherence to regulatory requirements and internal quality standards.· Nonconformities: Identify, assess, and address nonconformities, implementing corrective actions to prevent recurrence.· CAPAs: Drive the CAPA process, including root cause analysis, corrective action planning, and effectiveness verification.· Critical Suppliers: Collaborate with cross-functional teams to manage critical suppliers and ensure their compliance with quality standards.· Document Revisions (Veeva Vault): Oversee document control activities, including revisions, approvals, and maintenance of documentation within the Veeva Vault system.· Change Controls: Evaluate and manage change controls, ensuring that changes are implemented in compliance with regulatory requirements.· Mock Batch Recall Reports: Contribute to the preparation and execution of mock batch recall reports to assess and improve the effectiveness of our recall procedures. Qualifications:· Bachelor's degree in a related field (e.g., Life Sciences, Engineering, Biochemistry, Pharmacist) + a minimum of 5 years of experience.· PHD Preferred.· Proven experience in quality assurance within the medical device industry.· Strong knowledge of regulatory requirements (FDA, ISO 13485) and quality management systems.· Experience with Veeva Vault or similar document control systems.· Excellent communication and interpersonal skills.· Detail-oriented with a focus on continuous improvement.