SANUWAVE · 2 weeks ago
Vice President Quality Assurance
Eden Prairie, MN
Full-time
Onsite
Director/Executive
$150K/yr - $200K/yr
20+ years expSANUWAVE is seeking a Vice President of Quality Assurance to oversee all aspects of quality assurance, quality engineering, quality control, and regulatory compliance. The role involves developing and implementing quality management systems, ensuring adherence to regulatory requirements, and leading a high-performing quality assurance team.
Medical Device
Responsibilities
Serve as the Management Representative with regulatory bodies and lead company-wide efforts to maintain compliance with FDA, ISO, and international medical device regulations
Prepare for and manage external audits, including FDA inspections, ISO certifications, Intertek audits, and notified body assessments
Collaborate with regulatory affairs to ensure product approvals meet all necessary quality and compliance standards
Manage processes and procedures for handling complaints/Vigilance Reporting and MDR’s
Help establish and improve company wide SOPs for Software Development, Cybersecurity, HIPPA compliance, etc
Manage the corrective and preventive action process
Lead the efforts to streamline company SOPs, including, but not limited to, product development procedures
Lead and scale a nimble, high-performing quality assurance team
Provide leadership, training, and professional development to ensure team members stay updated on industry best practices
Foster a culture of accountability, collaboration, continuous learning, and problem solving within the QA department
Work closely with Operations teams to align quality strategies with business goals
Serve as the Quality Management Representative (QMR)/Person Responsible for Regulatory Compliance (PRRC); Implement and maintain a robust Quality Management System aligned with FDA/QMSR, ISO 13485, MDSAP, and other global regulatory requirements
Ensure continuous improvement of QMS processes to enhance efficiency and compliance
Manage the internal audit process to identify areas for enhancement
Manage the content and presentation of Quality Management Reviews with senior leadership
Develop and implement quality improvement programs focused on defect reduction and process efficiency
Provide quality input during new product development to ensure compliance from concept to commercialization
Monitor key quality metrics and implement corrective and preventive actions (CAPAs) as needed
Establish risk management procedures in compliance with relevant standards
Work with engineering and manufacturing teams to identify and mitigate product and process risks
Ensure timely resolution of quality issues and non-conformances to minimize regulatory and business risks
Lead initiatives to ensure product safety, reliability, and performance meet or exceed customer expectations
Analyze customer complaints and feedback to drive quality improvements and enhance brand reputation
Develop training programs to strengthen quality awareness across the organization
Qualification
Required
Minimum of Bachelor's degree in Engineering, Science, Regulatory or related field or relevant equivalent experience
20+ years experience in leading quality and/or regulatory team in a medical device environment required
15+ years of experience adhering to FDA/QMSR, ISO, MDSAP and other similar regulations required
15+ years serving as the QMR/PRRC required
Proven ability to demonstrate success with previous quality management systems, documentation and process improvement within a fast paced environment
Strong leadership, communication, and organizational skills with the ability to collaborate cross-functionally and adapted in regularly changing environments
Hands-on, detail-oriented, and comfortable operating in a lean, fast-paced environment
Strong verbal and technical writing skills, attention to detail, and accuracy
Ability to multi-task, use sound personal judgment, reason and logic
Company
SANUWAVE
As an emerging leader in the development and commercialization of energy transfer technology, SANUWAVE presents products that help expedite wound healing on a cellular level.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Morgan Frank
CEO/Chairman Of The Board Of Directors
Pete Stegagno
Chief Operating Officer
Company data provided by crunchbase