Senior Quality Systems Manager
Why is the quality management system within the medical device industry important?
- Patient Safety. The QMS ensures the organization has processes and procedures in place to maximize patient safety in products and services.
- Compliance to laws and regulations (keep the organization in business). This industry is governed by laws and regulations. Not adhering to these laws and regulations can cause the organization extreme difficulties up to and including business stoppage. The QMS has processes and procedures in place to ensure the organization complies to all laws and regulations.
- Good product and processes. The QMS establishes processes and procedures to drive quality in product design and manufacturing. It also enables the business to assess risk, quickly respond to issues, and focus on continuous improvement.
How do you see the quality management system role evolving over the next 5 years?
- QMS Architect. In organizations the QMS processes and procedures have become layered and bureaucratic making it slow and inefficient. Information systems can be silos of data that is very difficult to mine. Today, organizations hunger for information quickly. These organizations will be looking for QMS leaders who can come in and improve the architecture of their processes, documentation, and electronic system interfaces/reporting capability.
- Supply Chain Management. Outsourcing to suppliers is nothing new. However there is ever increasing scrutiny from regulatory bodies in control and management of all tiers of suppliers. QMS leaders will be needed to create innovative ways of interfacing with suppliers and their QMS’s. Component certification, effective auditing, and robust metrics and escalation are key areas.
- Collaboration/Harmonization between multiple quality systems. As the medical device industry consolidates, there will be multiple QMS’s among the organization’s business units. Future trends will include harmonization of QMS’s and collaboration between QMS’s as more products are being developed by multiple business units.
What advice would you give to QS professionals in their early career?
- Find a mentor. Mentors are critical throughout your career. You need people that you trust to give you honest feedback and advice.
- Explore all the different areas of quality: Quality Systems, Product Quality, Quality Engineering, etc. Find areas that interest you where you can learn, excel, and lead.
- Find your passion. It’s true what they say: love what you do and you’ll never have to work a day in your life. It is a privilege to work in the medical device industry where we alleviate pain, restore health, and extend life in patients all over the world every day.
What are you most looking forward to regarding the Medical Device Quality Management System Conference?
This conference is a wonderful opportunity to engage, share ideas, network, learn, and think about how one can apply what they have learned in their organization.
Ray will be one of the distinguished speakers at the Medical Device Quality Management Systems Conference.