Missouri City, Texas, United States
As a Senior Consultant, my mission is to uphold the highest standards in medical device manufacturing through rigorous auditing and quality assurance. With a deep understanding of ISO 13485, MDSAP, and regulatory compliance, I lead audits that ensure products meet critical safety and effectiveness criteria. My recent role has focused on evaluating customer's quality systems to comply with EN ISO 13485:2016, ISO 9001:2015, MDR, and MDSAP, where meticulous attention to detail and a methodical approach are paramount. In the realm of Regulatory Affairs and Quality Assurance, my expertise extends to managing comprehensive internal audits and fostering continuous improvement. I have been instrumental in communicating compliance issues and collaborating with client management to resolve audit nonconformities. My skill in ISO 14971 and IEC 60601-1 standards contributes to my proficiency in risk management, enhancing product integrity and patient safety.
Auditing medical device mfg for (EN) ISO 13485:2016, ISO 9001:2015, MDR, MDSAP and Internal Audits compliance. SUMMARY: Plan and perform independent audits to evaluate and determine customer’s quality systems and/or products compliance to applicable standards and regulatory requirements. Perform and document audits following relevant published standard(s), regulatory requirements and company procedures. May lead audit team and be responsible for successful accomplishment of assigned project Review and forward audit reports, client responses to audit non conformities, and other technical documentation reports to Certification Specialist Inform client management through verbal and written communication of compliance issues, relevant standards and regulatory requirements Evaluate product nonconformance related to product processes and specifications Establish and maintain strong professional relationships with customers Maintain and expand technical expertise in specific product field
Ansh Labs develops and manufactures tools for biomedical research and clinical diagnostics. We serve life science researchers, physician researchers, hospitals, commercial laboratories, and public health agencies to assist with the research, diagnosis, treatment, and management of diseases. The products we develop make it possible to conduct important research in various clinical diagnostic areas.
Reports to the Director of RA/AQ and supports Millar’s QMS and processes, company wide training on relevant quality system documentation and procedures, serves as a backup for supporting and reporting on the Customer Complaint, support, CAPA, Internal Audit, and Management Review systems, including coordination of Corrective Action activities associated with these systems and the generation and analysis of compliance reports for the purposes of identifying opportunities for compliance and system improvements. The role also oversees document control processes and establishes procedures to control documents, data, changes to documents and data to meet business requirements and comply with the medical device applicable standards and regulations. Essential Responsibilities: Trends and maintains records of Corrective and Preventive Action reports. Publishes monthly recap of Corrective Action Board (CAB) meetings, Oversees CAPA database and creates CAPA metrics. Executes Internal Audits as requested and the Internal Audit procedure, conducts routine, follow-ups and for-cause audits, prepares reports, communicates findings and ensures corrective actions are appropriate and assigned in timely manner. Manages the physical approval signature process for documents, document changes and maintains all active and inactive or obsolete documents and provides all documents and document change records in Adobe Acrobat format. Reviews engineering documents, procedures and other revision-controlled documents and changes records for procedural format and content compliance. Oversees archiving activities for engineering project files, validation protocols, verification protocols, technical files, design history files, and quality system procedures. Attends the engineering meetings and provides support on engineering projects, as needed. Participates in semi-annual management reviews. Support FDA and notified body audits as well as customer QMS audits.
Active Medical Device, Lead Auditor at TÜV SÜD North America - (EN) ISO 13485:2016, ISO 9001:2015, MDD/MDR, MDSAP. SUMMARY: Plan and perform independent audits to evaluate and determine customer’s quality systems and/or products compliance to applicable standards and regulatory requirements. PRINCIPAL DUTIES AND RESPONSIBILITIES Perform and document pre-audits, registration audits, re-audits and surveillance audits following relevant published standard(s), regulatory requirements and company procedures. May lead audit team and be responsible for successful accomplishment of assigned project Review and forward audit reports, client responses to audit non conformities, and other technical documentation reports to Certification Specialist Inform client management through verbal and written communication of compliance issues, relevant standards and regulatory requirements Evaluate product nonconformance related to product processes and specifications Establish and maintain strong professional relationships with customers Maintain and expand technical expertise in specific product fields Perform other duties as assigned