CAPA Quality Engineer

Job Title: Sr. CAPA/Quality Engineer

Duration: 12 Months (Possible temp to hire)

Location: Arden Hills, MN 55112

Onsite Role

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.

Education/Experience:

• 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.