Quality Assurance Software Engineer
2 weeks ago
Contract Type: Remote
Role Overview: As a Quality Assurance Software Engineer, you will be responsible for developing and implementing a comprehensive QA strategy that aligns with regulatory standards and the company’s quality system. Your expertise will ensure the successful integration of new products and modifications to existing products.
Key Responsibilities:
- Formulate a project-specific QA plan that meets regulatory requirements such as ISO13485 and FDA standards, while managing risk and adhering to project timelines.
- Act as the voice of the customer by ensuring product quality and reliability through proactive engagement and timely feedback to stakeholders.
- Identify and assess quality risks associated with product development projects, escalating issues as necessary and facilitating resolutions with relevant parties.
- Evaluate deliverables from the Product Development team to confirm accuracy and efficiency in completion.
- Support the management of audit findings and corrective actions within the Product Development sector.
- Collaborate with quality and regulatory team members across various projects to provide updates and ensure effective quality guidance.
Essential Qualifications:
- Bachelor’s degree in Engineering, Computer Science, Biomedical Science, or a related field.
- A minimum of 5 years of relevant experience in a product development setting.
- Experience in auditing processes.
- In-depth knowledge of good design practices for software in both medical and non-medical domains, including familiarity with Design History Files (DHF).
- Exceptional written and verbal communication skills, with a proven ability to negotiate and influence stakeholders.
- Proactive approach with the ability to work independently and efficiently fulfill role responsibilities.
- Strong grasp of medical device quality standards and regulations, including ISO13485, ISO14971, IEC 62304/82304, and FDA 21 CFR Part 820.
- Experience with software development methodologies such as Agile and DevOps, along with knowledge of IEC62304/82304 risk classifications and testing requirements.
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