Shockwave Medical, Inc. is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Shockwave Medical aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.

Position Overview

The Quality IT Business Analyst in the medical industry will be responsible for bridging the gap between business needs and IT solutions, with a focus on quality assurance and regulatory compliance. The ideal candidate will possess a deep understanding of healthcare processes, regulations, and technology, along with strong analytical skills and a commitment to driving continuous improvement.

Essential Job Functions:

• Proficiency in business analysis techniques, including requirements elicitation, documentation, and validation.

• Experience with testing methodologies, tools, and practices, including test planning, test case development, execution, and defect tracking.

• Actively contribute to improving and standardizing the business analysis processes within the organization.

• Work closely with regulatory affairs teams to ensure that IT projects meet all relevant regulatory requirements and obtain necessary approvals.

• Document and communicate test results, compliance findings, and recommendations to stakeholders and regulatory authorities as needed.

• Provide expertise and guidance on quality and regulatory IT best practices, standards, and emerging technologies.

• Collaborate with cross-functional teams to identify opportunities for process improvement and optimization in quality related IT project delivery.

• Partner with other cross-functional teams to create and monitor integrations; ensuring integrations run successfully.

• Support compliance activities related to ISO 13485, ISO 9001, FDA and GDPR regulations.

• Partner with third party vendors, ensure timely resolution of issues and timely delivery.

• Address user issues/concerns in a professional/timely manner and ensure end-user satisfaction.

Requirements:

• Bachelor's degree in Healthcare Informatics, Health Information Management, Computer Science, or related field.

• Minimum of 10 years of experience as a Business Analyst or Quality Assurance Analyst in the healthcare industry.

• Proven experience in the quality assurance and regulatory compliance aspects of IT projects, preferably in industries such as healthcare, pharmaceuticals, medical devices, or a highly regulated sector.

• Experience with testing and validation of healthcare IT systems, including EHRs, medical devices, and clinical software applications.

• Knowledge of software validation and verification processes, including IQ/OQ/PQ for regulated industries.

• Familiarity with quality management systems (QMS), regulatory requirements, and standards such as ISO 13485, ISO 9001, FDA regulations, GDPR, or other relevant regulations depending on the industry.

• Excellent analytical, problem-solving, and critical thinking skills, with a keen attention to detail.

• Strong communication and interpersonal skills, with the ability to effectively collaborate with diverse stakeholders.

• Strong attention to detail with the ability to multi-task and prioritize tasks.

• Continuous Improvement mindset with superior analytical and problem-solving skills.

• Previous experience working in a SCRUM or Agile environment desirable.

• Ability to work in a fast-paced environment while managing multiple priorities.

Market Range: $136,000 - $170,000
Exact compensation may vary based on skills, experience, and location.

Benefits
Shockwave Medical offers a competitive total compensation package as well as the following benefits and perks:

Core Benefits:Medical, Dental, Vision, Pre-tax and Roth 401k options with a fully vested match, Short-Term and Long-Term Disability, and Life Insurance, Employer contribution toward Health Savings Account (HSA), Competitive PTO balance

Perks: ESPP, Calm App, Pet Insurance, Student Loan Refinancing, Spot Bonus awards

EEO Employer