Responsible for product quality engineering activities providing high level of hands-on support throughout the product life cycle, from conception to commercialization and post-market evaluation in a cross-functional environment. Responsible for all aspects related to the quality of Company products, as well as Quality System processes, to establish and maintain compliance to all applicable regulatory requirements. The ideal candidate will possess a “hands-on” approach to quality engineering for electro-mechanical and software-based products, combined with QMS process implementation and maintenance.
Essential Duties and Responsibilities
Establish, document, implement, and maintain a Quality Management System (QMS) that is functionally-compliant to FDA QSR-820 and / or ISO-13485:2016.
Leads Design Quality and Compliance activities for new product development, partnering with PD Engineers to ensure design control standards are met.
Ensures products are developed to meet customer expectations and regulatory requirements via comprehensive Design History File to support regulatory submissions.
Applies knowledge of Design Control and Risk Management activities throughout the product lifecycle
Leads Manufacturing Quality and Compliance activities for production of new and existing products
Manages quality and compliance of Supply Chain, including qualifying all contract manufacturing and component suppliers, conducting supplier quality audits, and establishing Receiving and Outgoing Inspection methods, tests, and tools
Manages product non-conformances via SCAR process, complaint handling and post-market data collection and analysis, including root cause determination and coordination of associated CAPA activities
Manages quality and compliance of in-house Production and Servicing (as applicable)
Develops, implements, and maintains the Document Change Control system
Serves as Quality lead for business system implementations and other special projects
Roles and responsibilities may be shifted to maximize customer and Company success
Bachelor’s Degree in an applied science or engineering field
7+ years of Design and Manufacturing Quality Engineering experience with electro-mechanical and software products
Experience establishing or maintaining a QMS compliant to FDA QSR-820 and/or ISO 13485:2016
Demonstrated competency utilizing ISO-14971, IEC-60601, IEC-62304, and IEC-62366 on past projects
Understanding of HIPAA and cybersecurity-related standards and guidance documents
Proven track record of success working with a globally-distributed manufacturing supply chain
Ability to work in a fast-paced startup where “many hats” must be worn
Exceptional analytical, problem-solving, and interpersonal communication skills
Understands and can subsequently explain complex quality details to non-experts
Exceptional organizational skills and attention to detail
Knowledge and experience with ERP/MRP systems and their applications
Administrative and financial management skills relative to job expectations
Willing and able to travel when required, up to 40%, domestic and international
We are a growing strategic-backed startup based in the Philadelphia region developing a new-to-the-world medical device. Our key focus is a wearable airbag to protect against fall-related major hip injuries, which represents a leading cause of disability and death in the older adult population. We’re looking for passionate individuals to join our mission to redefine the standard of care for seniors at risk of falls. For more information, visit www.tangobelt.com.