HS Design Inc.

HS Design is a product development firm with a focus in the medical, healthcare, and life science marketplace. For over 40 years HSD has been rcognized for expertise in the areas of design research, human factors, user experience, industrial design, and product engineering. HSD is FDA compliant and ISO 13485:2016 certified with team members proudly serving on the AAMI Human Factors Committee and assisting with the Use and Usability Guidance documents (ISO and IEC 62366).

HS Design is part of the SteriPack Group, a global contract manufacturer for medical devices with manufacturing plants in Florida, Poland, Ireland, and Malaysia and additional development locations in Colorado and Poland. 

Jan 06, 2022  
$90,000 - $120,000 yearly
Reporting to the VP of Design & Development, the Quality Manager is responsible for maintaining the Quality Management System by updating and creating standard operating procedures, work instructions, and forms that comply with ISO-13485 and other standards. In addition, the Quality Manager will work with the R&D teams to create and approve quality and risk related specifications. Duties & Responsibilities: Drive key changes and continuous improvement in site Quality systems and procedures Liaise with other Design and Development sites within SteriPack to develop best QA practices Serve as the Quality engineer in programs, helping to create and/or review and sign quality related documents such as Design inputs, FMEAs, Hazard analysis, Trace Matrixes, Prints, Protocols, and Reports Serve as the Quality Management Representative during quality audits Respond to audit findings by creating and following through on action plans and CAPAs Assist in the...
HS Design Inc. 906 Mount Kemble Avenue, Morristown, NJ, USA Full time