Joseph Commane Email & Phone Number

Dallas, Tx, Us

Denton, Texas, Us

Monroeville, Pa, Us

Led and contributed to quality and regulatory projects throughout the full lifecycle of the medical device manufacturing process. Collaborated effectively with cross-functional teams on large-scale client projects, providing both guidance and leadership to drive successful outcomes and deliverables. Developed specialized expertise in key quality and regulatory areas, including:• Quality Management System (QMS) Development, Implementation, & Remediation• Design Assurance/Design Controls• Product Realization• EU MDR/IVDR Remediation• Technical Documentation Review/Remediation• Corrective and Preventive Action (CAPA) Management• Risk Management• Inspection Readiness & Audit Defense Strategies• Regulatory Submissions (US & OUS)• Post-Market Surveillance (PMS)

Monroeville, Pa, Us

Chicopee, Massachusetts, Us

Worked to optimize the function and quality of a variety of medical device systems within a GMP-regulated manufacturing facility. Some of my responsibilities included:• Continuous process improvement• Investigation of non-conforming product to determine the root-cause of the issue • Made changes/updates to controlled documents via red lining or engineering change requests• Developed and updated SOPs and other work/testing instructions• Assisted with Internal GMP auditing• Provided oversight into the device history records to ensure data was within specification • Ensured proper testing procedures were being followed correctly• Assisted with the review of validation protocols and reports • Responded to customer complaints, CAPAs, & SCARs (Post-market surveillance)

Dublin, County Dublin, Ie

This was an unpaid capstone project per MSU's College of Engineering where I had the opportunity to practice and implement multiple engineering principals to research, design, & select a new spray nozzle capable of enhancing the efficacy of the cleaning procedure within Perrigo's pharmaceutical manufacturing facility located in Allegan, Michigan. Some of my responsibilities included:• Applied engineering principals associated with fluid mechanics, the environment, heat transfer, biology, medicine, statistics, & dynamics• Developed a cost analysis for the design, outlining projected savings in time, labor, & water usage• Developed a risk assessment to evaluate the safety of the spray nozzle and its cleaning effectiveness • Created a drawing of the selected design using AutoCAD• Participated in on-site testing of the nozzle • Drafted technical reports and gave thorough presentations Overall, it was a great, yet challenging project experience that transformed our teams' understanding of not only the complex engineering systems, tools, and practices involved within a pharmaceutical facility, but also our understanding of how heavily regulated the industry is so that consumers know they are getting high quality products.