Vice President Quality Assurance

This range is provided by SANUWAVE. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$/yr - $/yr

The VP of Quality Assurance is responsible for overseeing all aspects of quality assurance, quality engineering, quality control, and regulatory compliance within the organization. This includes developing and implementing quality management systems, ensuring adherence to FDA/QMSR, ISO, MDSAP, and international regulatory requirements, and fostering a culture of continuous improvement. This position will work closely with cross-functional teams, including manufacturing, operations, R&D, sales, clinical, and marketing to enhance product safety, reliability, and compliance.

The VP of Quality Assurance must exhibit strong leadership skills, the ability to manage teams with a proactive, collaborative approach to risk mitigation and quality agility, and excellence.

ROLES AND RESPONSIBILITIES Ensure Regulatory Compliance and Audit Readiness

• 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.

Leadership Oversight

• 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.

Develop and Oversee Quality Management Systems (QMS)

• 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.

Lead Risk Management and Mitigation Strategies

• 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.

Enhance Product Quality and Customer Satisfaction

• 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.

MINIMUM EXPERIENCE AND EDUCATION REQUIREMENTS

• 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.

Seniority level

• Executive

Employment type

• Full-time

Job function

• Quality Assurance and Management
• Medical Equipment Manufacturing

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