Precise Solutions is hiring a
Senior Quality Assurance Engineer, Remote - Worldwide
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Senior Quality Assurance Engineer
🏢 Precise Solutions
💵 $181k
📍Worldwide
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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
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Please let Precise Solutions know you found this job on JobsCollider. Thanks! 🙏