Senior Quality Engineer—Software & Systems

Job Summary

This is a hands-on role where the Sr. Quality Assurance Engineer will apply diversified knowledge of engineering, quality principles and practices for medical device products and in vitro diagnostic devices (EU and FDA). This individual will ensure that all system-level projects deliverables (e.g., plans, requirements, specifications, tests, test results, traceability, risk management documents, reports) meet quality and compliance requirements.

Key Accountabilities

• Lead risk management initiatives for the entire product lifecycle in accordance with ISO
  14971 and related regulatory requirements. Assure applicable quality decisions are derived from the appropriate risk management document in accordance to the quality system.
• Independently manage and facilitate new risk assessments from initiation to completion working cross-functionally to develop risk management plans with key stakeholders that are robust and compliant with all procedural and regulatory requirements.
• Collaborate at a systems level with R&D, Clinical, Information Services and other key functions to identify risks, implement risk control measures, and document a robust and living risk management file.
• Review and provide feedback for changes to designs and processes and assess their impact to assure risk management requirements are met.
• Support on-going product compliance technical documentation and on-going market authorizations through review and response to competent authority feedback in a timely manner.
• Support teams to establish product development requirements e.g., Design Input Document, Design Verification and Validation requirements, Risk Management requirements, Usability requirements, CTQ Identification, etc.
• Support DHF content completion, collaboratively communicating and resolving regulatory compliance gaps.
• Serve as a Quality Core Team member on sustaining product lifecycle project and new product development teams. Represent Quality for new and existing product improvement and quality plan initiatives.
• Assist in the QA review and approval of process of software validation and cyber security qualifications (IQ, OQ, PQ).
• Assist in QA review and approval of software user acceptance testing.
• Provide Quality Engineering support for Quality Management System Software and operational continuity, including user/role administration, reporting and audit-log review, publication and authentication troubleshooting, and coordination with IT and for issue resolution.
• Provide Quality oversight for Quality Management System software configuration, development, and lifecycle changes, including workflows, packets, life cycles/vaults, integrations/imports, upgrades, and major system or process changes; support risk assessment, change control, testing, validation, and implementation in accordance with applicable quality-system requirements.
• Assess and provide Quality oversight for IT and software changes throughout the lifecycle, including evaluation of potential impact to product quality, patient/user safety, data integrity, regulatory compliance, and validated state, with ongoing assessment of cybersecurity hazards and associated risk controls.
• Performs other duties and responsibilities as assigned

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Networking/Key relationships

Work with the assistance of the Senior QA specialist on assigned projects and tasks. Support internal and external audits and audit responses to existing products. Partners with Regulatory Affairs to provide input to and review of regulatory assessments and submissions.

The Sr. Quality Assurance Engineer must be able to communicate clearly across all disciplines…