Primary Job Function

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

Minimum Qualifications                                                                              

• 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