Param Shah

Senior Quality Engineer @Camber Spine

Developed risk management and quality plans, Preliminary Hazard analysis, FMEAs (Usability, Design and Process), conducted risk reviews, verified implementation and effectiveness of risk controls, and monitored post market activities. Updated the risk management process to match with ISO 14971:2019 and worked with Marketing to create an effective survey/feedback form for surgeons to update all existing and new product risk related documents as part of DHF Remediation project. Created and provided management review each year to upper management and worked to maintain projects and resources for quality team Worked onboarding new suppliers to Approved supplier list (ASL), worked alongside supply chain to review and rate suppliers each year and reviews non comformances (NCR), deviations, CAPA/SCAR originated by CMO suppliers. Owned/Authored CAPA and work with cross-functional team to provide and document corrective/preventative actions and making sure steps were in place for effectiveness check to close out CAPA. Represented Quality as a person of contact for US and OUS(Mexico) registration and submissions of products for business expansion, worked alongside Marketing and PD to create, review, and provide all necessary documentation for registration to COFEPRIS. Created new SOPs for project creation and change order to simplify the process and trained all appropriate staff to adhere to Good Documentation Practice. Evaluated product design changes and process changes for verification and validation requirements and assisted in change implementation by review, redline and approve protocols and reports for FDA submission. Participated in and support all 3rd party audits(Front room for ISO 13485 surveillance and re-certificate audits by BSI) and supplier audits, including tissue product suppliers. Performed Gap assessment for all current DHFs and working on updating obsoleted documents to newer standards and procedures via DHF Remediation process.