Quality

Companies invest significant capital in designing and developing innovative products, following the correct process for regulatory approval and investing in the manufacturing personnel and equipment to bring their products to the world. Design control oversight, setting up risk management files, V&V, QMS oversight and quality strategy leadership are imperative to mitigate risk, protect your investment, ensure product integrity and patient safety.

Our business is people and helping you identify, attract and retain the top Quality talent to support your US and international strategies for your organization. SSI helps client companies identify, attract and retain the right Quality talent to support their innovative thinkers, support NPD, set up and oversee supplies/vendors, support validation and support manufacturing to ensure the safety and quality of their products in the marketplace.

We have the experience, skill and resources in our Quality practice to meet your needs in a variety of functional areas at the VP, Director, Manager and Mid-Level:

• Design Quality & Design Controls
• Risk Management, DFMEA, PFMEA
• Test Method Validation
• V&V, Validation: IQ/OQ/PQ
• QMS
• SPC, DOE
• ISO 13485:2016, ISO 14971, IEC standards
• Root-Cause-Analysis
• CAPA, NCMR, SCAR
• Supplier Quality
• Auditing- FDA, Supplier, Internal

Our clients range from start-ups, private small businesses, mid cap companies to publicly traded and top 30 global medical device and biotech companies in the world.