Quality Systems Engineer II
Description
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.
Description
In compliance with FDA, European MDD/MDR & other International Regulations, the Quality Systems Engineer II will perform work under supervision. The general scope of this position is to support NCR process, CAPA process, internal and external audits, data analysis and monitoring of the key process metrics. This position requires frequent use and general knowledge of industry practices, techniques, and standards.
Essential Job Functions
- Assist with audit activities.
- Participate in external and internal inspections/audits.
- Assist in the coordination of audit-related activities (preparing documents, tracking audit requests, taking notes, scheduling conference rooms, setting up communication channels, etc.)
- Assist in preparing and conducting the internal audits. Assist in maintaining a constant state of inspection readiness throughout all QMS.
- Manage the NCR System
- Work cross-functionally with other teams to track and manage NCR/Rework/Deviation activities from initiation through closure.
- Assist with affected product identification, segregation, investigation, and final disposition.
- Conduct periodic meetings with the Material Review Board (MRB) to present NCR trends, reports, and additional data analysis as required.
- Identify and implement continuous improvement activities for the QMS system in the NCR process.
- Maintain NCR procedures and records per procedure requirements.
- Compile quality metrics for trending purposes
- Compile data and prepare presentations as needed for periodic reviews of the following Quality systems: NCRs, Rework, etc.
- Work cross-functionally with other teams to compile and generate periodic reports in a timely manner to support quality systems activities
- Support company goals and objectives, policies, and procedures, QSR, and FDA regulations
- Other duties as assigned
Requirements
- Bachelor’s degree in related Engineering (Industrial, Quality, others)
- English Proficiency
- 2+ years of experience in related positions in the medical device industry.
- Basic knowledge of CGMP’s, FDA, ISO13485, MDR and other global laws, regulations and standards. ISO 14001 knowledge is a plus.
- Experience performing and approving NCRs, and CAPAs.
- Ability to compile and analyze data, present information, and demonstrate competent document writing skills.
- Ability to perform internal audits. ISO 13485 Internal Auditor Certification is a plus.
- A commitment to quality and a high level of self-motivation.
- Problem solving capability, ability to drive implementation of root cause identification and corrective actions.
- Excellent verbal and written communications skills.
- Strong interpersonal skills and an ability to work as an effective member of a cross-functional team.
- Excellent organizational skills and high attention to detail.
- Proficiency in data compilation, analysis, presentation, and document writing skills.
- Familiarity with statistical data analysis tools and concepts.
- Excellent working knowledge of computer-based applications (MS Word, MS Excel, Virje is a plus).
- Strong time management skills and the ability to multi-task in a fast-paced environment.
- Operate as a team and/or independently while demonstrating flexibility to changing requirements.
Benefits
Shockwave Medical offers competitive total compensation packages in line with market requirements.