Job Description

Job Description

Are you an experienced Quality Engineer with a desire to excel? If so, then TALENT Software Services may have the job for you! Our client is seeking an experienced Quality Engineer to work at their company in Arden Hills, MN.

Position Summary: This position on the Field CAPA and Design Quality team will lead cross-functional teams to determine actionable root causes and implement effective solutions for high-visibility issues impacting Active Implantable & Accessories product performance within the Cardiac Rhythm Management and Diagnostics (CRMDx) division. This role is for a strong technical individual with an innate technical curiosity who is seeking leadership, complex problem-solving, and project management experience. This individual will collaborate and partner with Research & Development, Regulatory, Marketing, Medical Safety, Manufacturing, Post Market, and other Quality organizations to achieve optimal results. They will also support other Design Quality work and projects as required in the areas of risk management, new product development, and sustainment.

Primary Responsibilities/Accountabilities:

• Lead cross-functional teams on complex product performance investigations, where the suspected root cause is product design, including Nonconforming Events and Preventions (NCEPs), Corrective and Preventive Actions (CAPAs), and Field Action recommendations if applicable.
• Lead collaborative problem solving of complex technical issues using disciplined, methodical techniques such as DMAIC, Root Cause Analysis, 5 Whys, Cause & Effect Diagram, and Is-Not.
• Create, maintain, and enhance cross-functional team partnerships by providing guidance regarding technical strategies and approaches; work cross-functionally and across multiple sites in identifying and resolving technical issues.
• Create and maintain detailed investigation documentation following Good Documentation Practice guidelines.
• Create, review, and approve Quality System records for NCEPs and CAPAs.
• Present updates in formal and informal reviews with all levels of the organization including high senior leadership.
• Mentor and guide other cross-functional teams and engineers by providing technical guidance and consulting on execution of NCEPs and CAPAs, which may include consulting across other divisions.
• Focus on continuous improvement by championing and fostering the execution of projects within the local and divisional Design Assurance organizations.
• Foster a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Monitor and ensure compliance with company policies and procedures.
• Demonstrate a primary commitment to patient safety and product quality by maintaining compliance to the Quality Systems Duties and Responsibilities.
• Build quality into all aspects of work by maintaining compliance to all quality requirements, Quality Policy, and all other documented quality processes and procedures.

Qualifications:

• 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.
• Experience in the Medical Device industry.
• 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.

Preferred:

• Experience with Active Implantable medical technologies.
• Demonstrated technical problem-solving & data analysis capabilities.
• Experience with statistics and statistical analysis tools (e.g., MINITAB, Weibull).
• Strong ability to successfully multi-task and demonstrate adaptability.
• Project management experience (direct or cross-functional teams).
• Strong business acumen and communication skills, with the ability to quickly establish impact and consequences.
• Ability to collaborate and influence across multiple, cross-functional teams.
• Demonstrated experience managing and leading multiple projects covering diverse engineering (i.e., Software, Hardware, Labeling) disciplines and functions.
• Self-starter with the ability to identify improvement opportunities.
• Comfort speaking to groups of individuals including divisional senior leaders.

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