Precise Solutions is hiring a
Senior Quality Assurance Engineer, Remote - Worldwide

Summary

The job is for a Quality Assurance professional focusing on SaMD and Digital Health Software Product Development. The position is remote within the US and offers competitive compensation including benefits. A Bachelor's degree or equivalent is required with preferably 5+ years of industry experience in Quality Assurance, Development, or a healthcare-related field.

Requirements

• Bachelor’s degree or equivalent is required; preferably in sciences, engineering or other technical/scientific area
• Bachelor’s degree and 5+ years of industry or 3+ years and Master’s degree experience in Quality Assurance, Development or healthcare related field. Experience in Medical devices, specifically development of Software Medical Devices is desired
• Strong understanding of regulations and standards affecting software medical devices such as IEC 62304, 21 CFR 820.30 and EU MDR
• Experience with creation and maintenance of QMS documents for development of medical devices
• Experience in coordination and planning of complex activities and ability to identify and resolve complex problems through effective use of technical and interpersonal skills
• Product development experience (e.g. approaches for definition of requirements and specification setting for verification and validation). Practical experience in design control and risk management
• Effective use of oral and written communication skills to clearly communicate the quality position, and the actions necessary to resolve issues
• Interpersonal, team, leadership, and negotiation skills to handle conflicting priorities
• Strong oral and written communication skills, excellent interpersonal and cross-cultural skills required
• Capable of clearly presenting and justifying quality requirements to management

Responsibilities

• Perform QA activities related to Software as a Medical Device (SaMD) and Digital Health Software Product Development
• Ensure compliance with AbbVie’s software lifecycle policies and procedures
• Perform design control and risk management activities according to AbbVie's Quality System
• Partner with technical teams to ensure design control documentation (Risk Management, Traceability/Linkages) & design change control requirements are met
• Support the creation of regulatory submission documentation
• Identify gaps/improvement opportunities within the Design History File and Risk Management and track to closure
• Initiate assignments independently. Actively lead and participate on development and process improvement teams
• Actively monitor effectiveness of processes and quality of project work, propose and execute quality/process improvements

Benefits

Competitive compensation including benefits such as health insurance, paid time off, and company 401k contributions