• Quality Engineer III

    US Tech Solutions (St. Paul, MN)


    Duration: 12 Months Contract (Possible Extension)

     

    Onsite position/ AH

     

    + Strictly on W2 Contract.

    + Possible temp to hire for right individual and if budget allows.

    Scope:

    + This **Quality Engineer III 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 (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.

    Responsibilities will include:

    + Leads cross-functional teams on complex product performance investigations, where suspected root cause is product design. Includes Nonconforming Events and Preventions (NCEPs), Corrective and Preventive Actions (CAPAs), and Field Action recommendations if applicable.

    + Leads collaborative problem solving of 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 at.

    + Mentors and guides other cross-functional teams and engineers by providing technical guidance and consulting on execution of NCEPs and CAPAs. May include consulting across other BSC divisions.

    + 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.

    + Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the

    Minimum 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 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 Qualifications

    • Experience with Active Implantable medical technologies

    • Demonstrated technical problem-solving & data analysis capabilities

    • Experience with statistics and statistical analysis tools (e.g. MINITAB, Weibull++)

    • Project management experience (direct or cross-functional teams)

    • Demonstrated experience managing and leading multiple projects covering diverse engineering (i.e. Software, Hardware, Labeling) disciplines and functions.

    About US Tech Solutions:

    US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To learn more about US Tech Solutions, please visit www.ustechsolutions.com.

     

    US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.