Quality Assurance (QA) Director Reviews - Page 5

Need full knowledge of QMS. Include FDA 21CFR820, ISO13485, MHLW169, etc for global requirements for a quality system. It helps to have auditor certification (ISO 13485 RABQSA Lead Auditor cert.).

A Quality Director must be EXTREMELY organized and efficient. A filing system is essential because someone will ask you, 5 years after the fact, if you know where to find a document. Don't be a bully - just report deficiencies to management and let them deal with corrections.

Sometimes the hardest problems are solved by taking some time stepping back and looking at the big picture. FOCUS on long lasting and sustainable solutions, rather than fixing the symptoms, otherwise you spend your work-life putting out fires and those are the ones that consume your energy and motivation the most. Don't be afraid to say "we wont fix it today, but we will fix it for good". Most importantly, always be transparent and communicate timely any risk or delays as soon as they are detected. Projects will always be affected by variables, is the timely actions and corrective adjustments that make a great project manager.

As a Directory of Quality your role is to ensure the product or service your company creates/provides meets or exceeds the expectations of its customers. Typically you are involved in resolving complaints, improving processes and procedures, and ensuring day to day operations fall withing the guidelines.

Remember that this is a business, so be somewhat flexible--i.e. Don't hold a hard line but raise the bar whenever possible.