Ensure overall qualityThe supplier quality engineer takes on the tasks of documentation, devising quality tests and defining the criteria a test result should meet. This engineering specialty also plays a role in correcting issues with manufacturing or materials resources when they arise. Early engagement of a supplier quality engineer is one of the most under-utilized opportunities in medical device development. It pays to know that your manufactured medical device or life science product meets safety standards and market expectations.
Overcome weaknessesSupplier quality engineers work with stakeholders at every phase of manufacturing. They identify product weaknesses and test for durability. The SQEs source suppliers to ensure raw materials and components meet standards. Quality engineers also oversee the teams performing manufacturing processes to ensure your quality standards are met.
Collaborate for complianceWe can help your R&D team to identify potential production challenges and ensure that your processes avoid them. By enlisting the help of a supplier quality engineer early, the development of your device can progress efficiently and effectively the first time around. Contact us today.
How We Can Help
We can advise you when a SCAR is needed and when a nonconformance report suffices. We know how to prepare both. Our goal is to protect your production and satisfy regulators.
First Article Inspection is a key initiative that ensures your manufactured medical device meets all quality, safety and efficacy requirements. Our experienced supplier quality engineer(s) work with your selected suppliers to oversee and ensure compliance.