Software CAPA Owner

Job Title

Job Description

Software CAPA Owner

Be the Driving Force Behind Quality & Innovation!
Join our team as a CAPA Owner at Image Guided Therapy Systems and take the lead in ensuring product safety, compliance, and excellence. You'll own the CAPA process from start to finish—investigating issues, identifying root causes, and implementing impactful solutions. Your work will directly enhance patient safety and product quality while keeping us ahead in regulatory standards. Ready to make a real difference? Apply now and be the expert who drives lasting change!

Your role:

• CAPA Leadership: Own CAPA investigations end-to-end, leading cross-functional teams to resolve quality issues efficiently.
• Root Cause Analysis: Use tools like 5 Whys, Fishbone, and FMEA to uncover the root causes of quality problems.
• Data Analytics: Analyze quality data (e.g., complaints, defects, system logs) to spot trends and support root cause findings.
• Project Management: Create and execute action plans with clear goals and timelines, ensuring CAPAs are implemented effectively.
• Documentation & Reporting: Maintain clear, concise CAPA records and reports for audits, regulatory needs, and stakeholder updates.
• Regulatory Compliance: Ensure all CAPA activities meet QMS, GMP, and medical device regulatory standards.
• Continuous Improvement: Promote process improvements using data insights, lessons learned, and quality best practices.

You're the right fit if:

Minimum requirements:

Minimum required Education:
Bachelor's / Master's Degree in Computer Science, Software Engineering, Information Technology or equivalent.

Minimum required Experience:
Minimum 5 years of experience with Bachelor's in areas such as Software Development, Software

Design and Architecture, Testing and Quality Assurance or equivalent.

Preferred requirements

• Extensive experience (5+ years) in Research and Development within the medical device industry, with a focus on structural problem-solving methodologies.
• Proven expertise in root cause analysis techniques and problem-solving methodologies.
• Project management skills, with the ability to lead cross-functional teams and drive initiatives to completion.
• Strong conceptual thinking with the ability to quickly grasp new knowledge areas; capable of breaking down complex problems into manageable work packages, leveraging Subject Matter Experts when necessary
• Good communication and interpersonal skills, with the ability to influence stakeholders at different levels of the organization.
• Understanding of quality management principles, methodologies, and regulatory requirements (e.g., FDA 820.x, ISO 13485, IEC62304 standard).
• Certification in quality management (e.g., ASQ Certified Quality Engineer, Six Sigma Black Belt) is a plus.

How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.

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