Job Description
Job Description
We are seeking a highly skilled Sr Quality Systems Specialist to join our Quality Department here at SANUWAVE. The ideal candidate will have strong Quality Systems expertise with a strong focus in Document Control and Records Management, advanced experience with Grand Avenue QMS software, and a proven track record of supporting regulatory and ISO 13485 audits ensuring compliance with ISO 13485, FDA 21 CFR 820. This individual will play a critical role in ensuring compliance, driving quality initiatives, and maintaining operational excellence across all aspects of our quality systems.
ROLES AND RESPONSIBILITIES
- Manage document control and records management processes in alignment with ISO 13485 standards.
- Maintain and optimize Grand Avenue QMS software to support departmental workflows and compliance requirements.
- Support external regulatory and notified body inspections, and coordinate efforts for internal audits, ensuring all applicable processes, documentation and procedures are audit ready.
- Oversee CAPA (Corrective and Preventive Action) and Nonconformance systems, ensuring timely and effective resolution.
- Provide guidance and mentor stakeholders on the practical application of QMSR and ISO 13485 requirements across the organization.
- Assist in continuous improvement initiatives to enhance the effectiveness and efficiency of the Quality Management System.
MINIMUM EXPERIENCE AND EDUCATION REQUIREMENTS
- Bachelor’s degree or equivalent
- Minimum of 5+ years in a regulated industry environment
- Advanced proficiency with Grand Avenue QMS software.
- Demonstrated proficiency in managing CAPA and Nonconformance systems.
- Practical working knowledge of ISO 13485 quality system requirements.
- Excellent organizational, communication, and problem-solving skills.
- Ability to work independently and collaboratively in a fast-paced environment.
- Preferred experience with Microsoft and Minitab software