Staff Quality Assurance Engineer
About The Position
The Staff Quality Assurance Engineer is responsible for owning quality related processes, guiding cross-functional teams through Beckman’s quality management system requirements, and ensuring product quality for Beckman’s customers. This position reports to the Senior Manager Manufacturing Quality and is part of the Quality & Regulatory Affairs organization located in Indianapolis, IN. This will be an on-site role. In this role, you will have the opportunity to: Represent Quality Assurance on cross functional teams tasked with business critical initiatives ranging from quality improvement projects to new product transfers and launches. Apply your insight of current industry standards and regulations and how they relate to internal policies and procedures. Influence interpretation of internal policies and procedures to ensure quality and compliance. Serve as a local process owner and subject matter expert for Production & Process Controls as well as other manufacturing related QMS processes. Coach teams with application of ISO 9001/13485/cGMP and quality systems processes throughout product lifecycle Leverage data analytics and business intelligence tools to identify quality trends, monitor process performance, drive risk-based decision making, and communicate actionable insights to leadership
Requirements
- Demonstrated experience supporting the manufacture of medical device instruments, electromechanical systems, laboratory instrumentation, diagnostic analyzers, automation platforms, or similar complex medical devices.
- Proven experience applying quality and regulatory requirements to manufacturing processes, process validation, equipment qualification, nonconformance management, CAPA, risk management, and continuous improvement activities.
- Working knowledge of ISO 9001 & ISO 13485 standards, and 21 CFR Part 820 & EU MDR/IVDR regulations
- Bachelor’s Degree (minimum) in engineering or other science or related field; or equivalent experience required.
- 7+ years' experience (or 4+ years with Master's Degree) in Quality Engineering, Manufacturing Engineering, or Quality Systems within regulated industries.
Nice To Haves
- Advanced Power BI (or similar) capabilities including data modeling, DAX development, Power Query, dashboard design, KPI development, and integration of data from ERP, eQMS, manufacturing, and other enterprise systems
- Quality Engineering tools such as Six Sigma, DMAIC, Statistical Process Control, 5 why’s, 8D, PFMEA, Design of Experiment, etc.
- Oracle as an ERP and IQVIA as an eQMS
Responsibilities
- Represent Quality Assurance on cross functional teams tasked with business critical initiatives ranging from quality improvement projects to new product transfers and launches.
- Apply your insight of current industry standards and regulations and how they relate to internal policies and procedures.
- Influence interpretation of internal policies and procedures to ensure quality and compliance.
- Serve as a local process owner and subject matter expert for Production & Process Controls as well as other manufacturing related QMS processes.
- Coach teams with application of ISO 9001/13485/cGMP and quality systems processes throughout product lifecycle
- Leverage data analytics and business intelligence tools to identify quality trends, monitor process performance, drive risk-based decision making, and communicate actionable insights to leadership
Benefits
- health care program
- paid time off
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What This Job Offers
Job Type
Full-time
Career Level
Senior
