Careers

ROLES AND RESPONSIBILITIES

• Answer incoming emails and phone calls from customers and sales reps related to product and process questions.
• Provide basic technical support and live troubleshooting for our devices and systems.
• Log all complaints into the ERP system and track progress using Excel spreadsheets.
• Guide customers through resolution of their issue from initial receipt to inspection/repair, QA review and final shipment ensuring a positive customer experience.
• Communicate expectations and steps throughout various complex processes, providing proactive updates to customers throughout their resolution process to ensure transparent communication and satisfaction.
• Provide thorough, friendly, written, and verbal responses to customers and internal teams related to orders and customer complaints.
• Handle initial intake of complaints providing the necessary troubleshooting before escalating to Quality Assurance, as needed.
• Utilize multiple tools and resources, including ERP systems, Excel, and Microsoft Teams to manage and monitor cases efficiently.
• Adhere to a robust process that ensures accuracy, accountability, and high-quality outcomes.
• Build and develop relationships with customers and sales team.
• Handle multi-step procedure of order processing including but not limited to contract verification, new customer and pricing set-up, sales and transfer orders, expediting, returns, consigned inventory, trunk stock, samples and demo.
• Create and update customer and pricing data and process sales/transfer orders using NetSuite.
• Prioritize the needs of customers and sales team via various means including phone calls, emails, and tickets.
• Manage consigned inventory including agreements, initial orders, bill and replace POs, and par level.
• Manage trunk stock with sales team including documenting field product transfers and physical inventory verifications.
• Resolve inventory discrepancies related to consignment of inventory and trunk stock.
• Manage sales demo units and sample products.
• Act as an advocate for customers by providing feedback on process, policy and workflow improvements.
• Other duties and projects, as assigned.

MINIMUM EXPERIENCE AND EDUCATION REQUIREMENTS

• At least 5 years of customer service experience with direct customer interactions including clinical, purchasing/procurement, and/or sales teams required.
• At least 1 year of medical device experience is required.
• Proven experience problem solving and prioritizing independently in a dynamic environment.
• Proven commitment to customer services including, but not limited to, positive attitude in the face of adversity, attention to details, clear and supportive communication written and verbally.
• NetSuite CRM experience preferred.
• Consignment inventory and trunk stock experience preferred.
• Start-up, rapid growth, and fast paced environment experience preferred.

ROLES AND RESPONSIBILITIES

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 processto identify areas for enhancement.
• Manage the content and presentation of Quality Management Reviews with senior leadership.

Ensure Regulatory Compliance and Audit Readiness

• Serve as the primary company contact 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, 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.
• Manage the corrective and preventive action process.

Drive Continuous Improvement Initiatives

• Develop and implement quality improvement programs focused on defect reduction and process efficiency.
• Monitor key quality metrics and implement corrective and preventive actions (CAPAs) as needed.

Lead Risk Management and Mitigation Strategies

• Establish risk assessment protocols, including Failure Mode and Effects Analysis (FMEA) and Hazard Analysis and Critical Control Points (HACCP).
• 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.

Oversee Supplier Quality Management

• Responsible for the overalll Supplier Quality management, ensuring supplier Quality Agreements are in place, and also ensuring qualification, auditing, and performance monitoring activities are conducted.

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.

Manage and Develop Quality Assurance Teams

• Build and mentor a high-performing quality assurance and quality control team.
• Provide leadership, training, and professional development to ensure team members stay updated on industry best practices.
• Foster a culture of accountability, collaboration, and continuous learning within the QA department.

Collaborate with Cross-Functional Teams

• Work closely with R&D, manufacturing, and regulatory affairs to align quality strategies with business goals.
• Provide quality input during new product development to ensure compliance from concept to commercialization.

MINIMUM EXPERIENCE AND EDUCATION REQUIREMENTS

• Minimum of Bachelor's degree in Engineering, Science, Regulatory or related field or relevant equivalent experience.
• 15+ years experience in leading quality and/or regulatory team in a medical device environment required.
• 10+ years of experience adhering to FDA/QMSR, ISO, MDSAP and other similar regulations required.
• 10+ 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.
• 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.
• Exhibit adaptability.

ROLES AND RESPONSIBILITIES

• Develop and continually maintain in-depth understanding of the wound care market, customers, and competition.
• Establish short and long-term tactics and strategies for SANUWAVE’s business opportunities.
• Build and maintain exceptional relationships across clients, key corporate accounts, and Key Opinion Leader using a collaborative approach, open communication and regular follow-up.
• Consistently identify and execute new business opportunities and maximize current customer growth opportunities.
• Manage current and forecasted opportunities for all sales activities; capture and maintain all requested information in SANUWAVE’s CRM, or other reporting tools as directed.
• Ensure compliance with, and implementation of, approved corporate directives and required operational activities.
• Regularly monitor, track, and report on sales performance and progress.
• Work within a given budget, providing timely customer feedback, and managing resources is an ongoing expectation.
• Work with Commercial Operations and Clinical team to ensure clients are vetted before placing devices and products.
• Act in a cost-conscious manner when managing travel and expense budget and adhere to SANUWAVE policies.
• Provide account specific information and/or assistance as requested by SANUWAVE to meet cross functional goals.
• Complete all assigned training and associated Quality and Regulatory activities in a timely manner.

MINIMUM EXPERIENCE AND EDUCATION REQUIREMENTS

• Minimum of 5 years of relevant experience in medical sales is required.
• Wound care experience highly preferred.
• Relevant sales and clinical experience required. Advanced degree preferred.
• Documented success of achieving/exceeding assigned quotas and/or KPIs.
• Proven ability to work independently to meet goals using exceptional time management skills, prioritization, and execution within a dynamic environment.
• Demonstrated business acumen with the proven ability to work independently as well as collaboratively in a cross-functional team environment.
• Proven experience interacting with a variety of people, including C-suite executives, to build relationships and gain useful contacts and opportunities.
• Excellent verbal, written communication including group and executive presentations.
• Proven experience using technology and analysis tools (Microsoft Office, Outlook, CRM databases, Sales Force, etc).
• Availability to travel 50 - 75%, at times, with minimal advance notice.
• Early commercial stage/start up experience strongly preferred.