Senior Design Quality Engineer - Remote / Telecommute

Cynet systems Inc; Jackson (MS); Remote; USD 70,000 - 90,000; Full time

Job summary

A quality assurance firm is seeking a professional in Jackson, Mississippi for a medical device regulatory role. The candidate must have 3+ years of experience in quality assurance, knowledge of regulatory standards, and strong problem-solving skills. Responsibilities include software validation, process improvement, and compliance with regulations. This role is essential for maintaining high standards and ensuring product safety and efficacy.

Qualifications

• 3+ years in medical device quality/regulatory roles.
• Familiarity with 21 CFR Part 11, 21 CFR 820, ISO 13485.
• Strong organizational and management skills.

Responsibilities

• Ensure software validation of non-product software systems.
• Collaborate with teams on development and production processes.
• Complete verification and validation of medical device systems.

Skills

Quality assurance

Regulatory compliance

Problem-solving

Interpersonal skills

Communication

Education

B.S. degree in Mechanical, Electrical, Biomedical, or Computer Science

Job description

Responsibilities

• Ensure software validation of regulated non-product software systems is executed according to established SOPs and produces compliant deliverables.
• Collaborate with cross-functional teams to model development and production processes in an item-based management system.
• Complete and support end-to-end verification and validation of integrated systems used in medical device production, distribution, and monitoring.
• Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
• Identify and implement process improvement methodologies where applicable.
• Ensure compliance with applicable regulatory requirements, procedures, and standards.
• Maintain project schedules, report progress, and present results to cross-functional teams.
• Support development and maintenance of design history files, design control activities, and risk management documentation.

Requirement/Must Have

• 3+ years of experience in medical device quality/regulatory roles.
• Familiarity with 21 CFR Part 11, 21 CFR 820, ISO 13485, ISO 14971, IEC 62366, IEC 62304, and other applicable regulations.
• Experience interpreting regulatory requirements and following standard operating procedures.
• Experience with design control and risk management activities for medical devices.
• Strong organizational, management, and interpersonal skills.
• Excellent verbal and written communication skills.

Qualification and Education

• B.S. degree in Mechanical, Electrical, Biomedical, Computer Science, or equivalent engineering/science discipline.

Preferred Skills

• Experience working on software used to produce or monitor medical devices (MES, configuration management systems, post-market surveillance systems, design and development systems).
• Cross-functional collaboration and experience interacting with engineering design teams.