What are the responsibilities and job description for the Design Quality Engineer position at ICONMA?
Our Client, a Consumer Products and Software Services company, is looking for a Design Quality Engineer for their Cupertino, CA/Hybrid location.
Responsibilities:
Responsibilities:
- Ensuring that Design Controls are properly executed in accordance to established standard operating procedures
- Leading risk management activities in relation to design changes, and issues discovered during internal testing, and in the field
- Completing and supporting design change assessments and completing design control documentation to support new software releases
- Identifying and implementing effective systems to support products post market
- Implementing the execution of systems which identify and resolve quality issues (CAPAs)
- Applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
- Implementing various product and process improvement methodologies
- Working with the teams on investigation, resolution and prevention of product and process non-conformances
- Complying with applicable regulatory requirements, procedures, and processes, requirements
- 3 years of medical device experience in a quality/regulatory role
- Familiarity with 21 CFR 820, ISO13485, ISO 14971, IEC 62366, IEC 62304 and other applicable regulations
- Experience interpreting requirements and following standard operating procedures
- Experience with design control, and risk management activities for medical devices, including development and maintenance of design history files
- Exceptional organizational and management skills
- Excellent interpersonal skills, both verbal and written
- B.S. ME/EE/BME/CS degree or equivalent in any engineering/science discipline
- Additional Requirements: Experience in working on software as a medical device (SaMD) products
- Health Benefits
- Referral Program
- Excellent growth and advancement opportunities
Salary : $56 - $59