Software QA Design Engineer

Position Overview: 

The Software QA Design Engineer will play a crucial role in ensuring the quality and safety of our medical device software. This position involves working closely with the development and manufacturing teams to validate and verify software, ensuring compliance with industry standards and regulations. The ideal candidate will have a strong background in Quality Management Systems (QMS), risk management, and software validation and verification (V&V).

QA Design Engineer Key Responsibilities:

• Develop and implement software QA processes in compliance with IEC 62304, ISO 13485, ISO 14971, and relevant CFR standards
• Ensure effective risk management practices are in place for validation and manufacturing processes
• Perform verification and validation (V&V) of software, ensuring it meets all regulatory and quality requirements
• Utilize Six Sigma methodologies to improve software quality and process efficiency
• Manage and maintain Quality Management Systems (QMS) by industry standards
• Work collaboratively with cross-functional teams, including software developers, manufacturing engineers, and regulatory affairs
• Use Jira for tracking and managing software defects and enhancements
• Provide expertise in regulatory compliance, particularly with medical device software standards

Qualifications / Requirements:

• Bachelor's degree in Computer Science, Engineering, or a related field
• Minimum of 5 years of experience in software quality assurance, preferably in the medical device industry
• Extensive knowledge of IEC 62304, ISO 13485, ISO 14971, and relevant CFR standards
• Strong understanding of risk management principles and practices
• Proficiency in Six Sigma methodologies
• Experience with Quality Management Systems (QMS)
• Hands-on experience with Jira for defect tracking and project management
• Excellent analytical and problem-solving skills
• Strong communication and interpersonal skills, with the ability to work effectively in a team environment

Benefits:

• Comprehensive health and dental insurance
• Pension plan
• Opportunities for professional development and career advancement
• Collaborative and innovative work environment

Reperio Human Capital acts as an Employment Agency and an Employment Business.