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Software Quality Assurance Specialist
2 months ago
Precise Solutions is seeking a highly skilled Quality Assurance Engineer to join our team in the development of Software as a Medical Device (SaMD) and Digital Health Software products.
Key Responsibilities:
- Represent QA on cross-functional teams and execute Quality System requirements to ensure products are developed, tested, and released in compliance with worldwide Medical Device Regulations.
- Author, review, and approve project documentation associated with the SDLC and design control requirements to support Corporate, Division, FDA, and other regulatory requirements.
- Create and maintain QMS documents for the development of SaMD's and Digital Health Software Products in compliance with global regulations.
Requirements:
- Bachelor's degree or equivalent in sciences, engineering, or other technical/scientific area.
- 5+ years of industry experience in Quality Assurance, Development, or healthcare-related field, with experience in Medical devices, specifically development of Software Medical Devices.
- Strong understanding of regulations and standards affecting software medical devices, such as IEC 62304, 21 CFR, 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.
Preferred Qualifications:
- Product development experience, including 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.
About Precise Solutions:
Precise Solutions is a leading provider of consulting services to the Life Sciences Industries. We offer competitive compensation packages, including salaries, benefits, health insurance, paid time off, and employer-based 401k contributions.
