Senior Software Quality Engineer, Instruments & Accessories

Company: Disability Solutions
Location: Santa Clara
Posted on: May 6, 2024

Job Description:

J&J MedTech is recruiting for a Senior Software Quality Engineer, Instruments & Accessories. This position can be located in Santa Clara or Irvine, California or Cincinnati, Ohio! At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at . This role is responsible for supporting product quality and reliability ensuring the implementation of ground-breaking technology for medical devices is safe and effective, while following applicable regulations, standards, and industry practices! Working closely with multi-functional teams, you will act as a domain authority for product quality throughout the development lifecycle. You will review and assesses development activities (e.g., user needs, development/quality plans, requirements, architecture and design, verification and validation) to ensure that they align with applicable procedures standards and regulatory requirements. Additional responsibilities may include supporting other areas of our Quality Management System such as CAPA, Complaints, post market surveillance and both Internal & External Audits. Key Responsibilities:

• Review all project/program software development artifacts (e.g., plans, requirements, specifications, test protocols, test cases, test results, traceability, risk management documents, reports).
• Provide direction and leadership for verification & validation of non-product software, products software, software tools and components.
• Guide in establishing good software requirements, specifications, detailed design, verification & validation protocols and planning documentation.
• Collaborate with project/program teams to ensure software deliverables and tasks align with company procedures, global standards (ISO 13485, ISO14971, IEC62304), regulations (e.g., 21 CFR Part 820, 21 CFR Part 11, European Union Medical Device Regulation (MDR)), and applicable guidance.
• Participate in technical design reviews and project phase reviews.
• Apply knowledge of risk management to ensure a risk-based approach for design and development.
• Identify and implement any changes vital to ensure and maintain the continued suitability and effectiveness of the quality system using policies, objectives, audit results, and analysis of data.
• Support internal and external audits by regulatory agencies, as needed.
• Communicate business related issues or opportunities to next management level.
• Ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Adhere to good documentation practices including change control.

Keywords: Disability Solutions, Carmichael , Senior Software Quality Engineer, Instruments & Accessories, IT / Software / Systems , Santa Clara, California