Infosoft, Inc. · 22 hours ago
Design Control/Quality Engineer (Medical Devices)-(W2 Only)
Irvine, CA
Contract
Onsite
Senior Level
$65/hr - $70.30/hr
5+ years expInfosoft, Inc. is seeking an experienced Design Control/Quality Engineer to support design control, production quality, and commercial operations for regulated medical devices. This role will involve collaborating with cross-functional teams to drive quality initiatives across the product lifecycle.
ConsultingDeliveryHuman ResourcesInformation Technology
No H1B
Hiring Manager
Jack J
Responsibilities
Own and support Quality Management System (QMS) activities in a regulated environment
Generate, review, and approve quality documentation (SOPs, reports, records, etc.)
Lead and support risk management activities throughout product development and production
Drive and contribute to design control–related projects, including design reviews and DHF support
Manage and support CAPA, investigations, root cause analysis, and effectiveness checks
Provide quality support to production, manufacturing, and commercial teams
Support production quality and product development processes
Collaborate with cross-functional teams including R&D, Manufacturing, and Regulatory Affairs
Support post-market surveillance activities (nice to have)
Participate in limited domestic travel (approximately 1 visit per quarter)
Qualification
Required
Bachelor's degree in Engineering (Biomedical, Mechanical, Electrical, or related discipline)
5–12+ years of Quality Engineering experience
Experience working with Class I, II, and/or III medical devices (required). Class III medical device experience strongly preferred
Strong knowledge of design controls, risk management, and regulated product development
Hands-on experience with CAPA, investigations, and problem resolution
Proven ability to operate independently in a regulated environment (FDA, ISO 13485)
Preferred
CQE certification (desired)
Post-market surveillance experience
Experience supporting both production and commercial stages of the product lifecycle
Company
Infosoft, Inc.
Infosoft is an HR services company focused on recruiting talent and building teams throughout the US market.
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase