Ecocareers · 1 month ago
Validation quality Engineer
San Diego, CA
Full-time
Onsite
Entry, Mid Level
2+ years expConfidential company is seeking a Validation Quality Engineer to provide technical and quality system guidance for establishing product software as a medical device requirements. The role involves quality oversight for verification and validation activities of new products, ensuring compliance with design planning procedures and US FDA regulations.
Staffing & Recruiting
Responsibilities
Leads meetings to prioritize, review and/or approve of action plans for addressing issues captured in problem resolution systems during development
Leads risk evaluation and associated management activities related to product software development including Risk assessments (e.g. FMEA), product risk analysis, and mitigation of software issues
Participates in technical and management reviews to ensure design plans, product design and deliverables related to product software are met. Represent the quality engineering function for the review and approval of designated design controls
May provide quality oversight for non-product software validation by assessing the need for validation and preparing and/or supporting protocols, reports and other documentation as required
May be involved with supporting product cybersecurity assessments in conjunction with a cross-functional team
Complies with US FDA regulations, other country regulatory requirements, company policies, and procedures
Maintains a strong, collaborative partnership with cross functional team members especially with software supplier
Works as an individual contributor and may provide guidance of other QE team members
Qualification
Required
Medical device – R&D product software
resource shall have a background in the medical/pharma domain
resource shall have product software validation experience and a minimum of 2 to 3 years of experience in Quality
Resource shall have experience as a Software Quality Engineer or Validation Engineer and Quality Engineer
Product software Quality, Design Controls, NPSW Validation, Risk Assessment & Mitigation, IEC 62034, ISO 14971
Company
Ecocareers
Ecocareers provides a specialized job search for careers that make a difference.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase