REQ Solutions ยท 1 day ago
CAPA Quality Engineer
St Paul, MN
Contract
Onsite
Mid, Senior Level
$60/hr - $65/hr
4+ years expREQ Solutions is a company seeking a Senior CAPA/Quality Engineer to lead cross-functional teams in determining root causes and implementing solutions for product performance issues in the Cardiac Rhythm Management and Diagnostics division. The role involves complex product performance investigations, supporting design quality work, and fostering a diverse and inclusive workplace.
Outsourcing/Offshoring
Hiring Manager
Deep Shah
Responsibilities
This Quality Engineer on the Field CAPA and Design Quality team will lead cross functional teams to determine actionable root cause and implement effective solutions for high visibility issues impacting Active Implantable & Accessories product performance within the Cardiac Rhythm Management and Diagnostics division
Leads cross-functional teams on complex product performance investigations, where suspected root cause is product design which includes Nonconforming Events and Preventions (NCEPs), Corrective and Preventive Actions (CAPAs), and Field Action recommendations if applicable
They will also support other Design Quality work and projects as required in the areas of risk management, new product development, and sustainment
Leads collaborative problem solving complex technical issues using disciplined, methodical techniques
Tools used include DMAIC, Root Cause Analysis, 5 Whys, Cause & Effect Diagram, and Is-Is Not
Creates, maintains, and enhances cross-functional team partnerships
Provides guidance regarding technical strategies and approaches; works cross-functionally and across multiple sites in identifying and resolving technical issues
Represents the team at key global and divisional leadership forums
Creates and maintains detailed investigation documentation following Good Documentation Practice guidelines
Creates, reviews, and approves Quality System records for NCEPs and CAPAs
Presents updates in formal and informal reviews with all levels of the organization including high senior leadership
Focuses on continuous improvement by championing and fostering the execution of projects within the local and divisional Design Assurance organizations
Fosters a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives
Monitors and ensures compliance with company policies and procedures
Qualification
Required
Bachelor's degree in an engineering or related discipline, plus 4+ years of relevant experience
Knowledgeable in Quality System Regulations, Medical Device Regulation, and ISO 13485 Quality Standards
Must have medical device experience
Experienced in Root cause analysis
Experience with non-conforming products/processes, CAPAs, Field Action decision making and other investigation processes
Proficient with Microsoft Office tools including Word, Excel, PowerPoint, and Outlook
Company
REQ Solutions
Experience the Power of Strategic Offshore Partnership with REQ Solutions' RPO expertise..
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase