Quality Manager (Medical Software)

About Us

We are a forward-thinking company specializing in the development of cutting-edge medical software. As an ISO 13485-certified organization, we prioritize quality and compliance in everything we do. With a focus on Class IIb medical devices under the EU MDR and FDA regulations, we are committed to delivering safe and effective products to improve healthcare worldwide.

We are seeking an experienced and detail-oriented Quality Manager to lead our quality assurance and regulatory compliance efforts.

Key Responsibilities

Quality Management System (QMS)

• Oversee, maintain, and improve the QMS in compliance with ISO 13485, MDR, and FDA requirements.
• Ensure that all processes, procedures, and documentation are aligned with regulatory and quality standards.
• Conduct regular internal audits and coordinate external audits with notified bodies and regulators.

Regulatory Compliance

• Develop and implement strategies for achieving MDR certification for Class IIb devices and FDA approval.
• Prepare and maintain technical documentation (e.g., DHF, DMR, risk management files, clinical evaluation).
• Act as the primary liaison with regulatory authorities, notified bodies, and other stakeholders.

Risk Management and Post-Market Surveillance

• Implement and manage risk management processes per ISO 14971.
• Oversee post-market surveillance activities, including incident reporting, corrective actions, and preventive actions (CAPA).

Leadership and Collaboration

• Provide guidance and training to cross-functional teams on quality and regulatory requirements.
• Foster a culture of quality across the organization.
• Lead the preparation for regulatory inspections and ensure timely resolution of any findings.

Continuous Improvement

• Identify and implement quality improvement initiatives.
• Monitor key quality metrics (e.g., non-conformance rates, CAPA effectiveness).

Qualifications

Education

• Bachelor’s degree in engineering, Life Sciences, or a related field. Master’s degree preferred.

Experience

• Demonstrated expertise with ISO 13485, EU MDR, and FDA 21 CFR Part 820.
• Experience managing Class 2b devices under MDR and obtaining FDA approvals.

Skills

• Strong knowledge of risk management (ISO 14971), usability engineering, and software lifecycle processes.
• Excellent written and verbal communication skills.
• Proficiency in quality management software and tools.
• Strong leadership and problem-solving abilities.

Preferred Qualifications

• Certification in quality or regulatory affairs (e.g., CQE, RAC, or equivalent).
• Experience with IEC 62304 (Medical Device Software Development).
• Familiarity with cybersecurity requirements for medical devices (e.g., FDA premarket guidance).

What We Offer

• Competitive salary.
• Opportunities for professional growth and development.
• A collaborative and innovative work environment.
• The chance to make a tangible impact on healthcare.

How to Apply

Interested candidates should submit their resume and a cover letter outlining their experience and suitability for the role to info@xspline.com