Jobs
>
Minneapolis

    Sr. Material Quality Engineer - Minneapolis, United States - Inspire Medical Systems I

    Inspire Medical Systems I
    Inspire Medical Systems I Minneapolis, United States

    2 weeks ago

    Default job background
    Description
    Job Description

    Job Description


    ABOUT INSPIRE MEDICAL SYSTEMS

    Inspire is the first of its kind medical device designed to make a difference in the lives of those living with Obstructive Sleep Apnea (OSA).

    We are revolutionizing the sleep industry with our FDA-approved medical device, designed to reduce OSA severity for those who cannot tolerate or get consistent benefit from CPAP.

    Our focus on patient outcomes is at the core of everything we do, and our "think I can" attitude drives us to make a difference in the lives of those seeking alternative sleep apnea treatments.

    WHY JOIN OUR FAST-GROWING TEAM
    At Inspire, we value people – your diverse experiences, backgrounds, and thoughts. We elevate voices and encourage learning opportunities to build a professional network that grows into community.

    We embrace a people-first culture by offering hybrid work schedules, excellent benefits, 401k matching, ESPP, flexible time off (FTO), and tuition reimbursement.

    If you're passionate about making a difference in people's lives and want to work with innovative technology, come be a part of our great team


    ABOUT THIS POSITION
    This position must provide expertise and leadership in the areas of component manufacturing, component inspection and supplier quality management.

    This person is responsible for performing tasks that will assure a high level of product reliability along with regulatory compliance.

    This position will work with Development, Operations, Manufacturing, Post Market Surveillance and other functional areas globally to ensure work is completed in accordance with Inspire procedures and geographic regulations.

    In addition, this role must be flexible for changing priorities, able to work without supervision and manage other personnel in the future.

    The individual for this position must be able to work well in a team environment, foster team building, proactively communicate task status, and operate with a high level of initiative, along with excellent verbal and written communication skills for effective communication with various levels of management.


    OPPORTUNITIES YOU WILL HAVE IN THIS ROLE
    Lead supplier qualification, supplier approval and component qualification process.
    Lead CFI and IP development processes for new and existing components.
    Provide expertise on component specifications as well as generating and approving ECOs.
    Lead supplier audits and manage supplier CAPA activities.
    Lead incoming component receipt activities and generate/manage MR requests as needed.
    Support process assurance activities (i.e.; manufacturing verification and validation).
    Support manufacturing risk management activities (i.e.; pFMEAs).
    Lead annual supplier reviews and support Operations in supplier quarterly business reviews.
    Generate and approve design history file documents, device master record documents and supplier change request records
    Lead/support cross-functional teams to resolve quality issues and complete CAPAs.
    Complete component incoming inspections as needed and manage external vendors for outsourced inspection activities.
    Develop and manage supplier metrics and scorecards using SPC tools as well as business intelligence tools (i.e., Power BI)
    Support QMS audits with both internal and external auditors.
    Ability to work efficiently and effectively in both a paper-based and electronic QMS.
    Recommend process improvements, driving both efficiency and compliance.

    Required Qualifications
    Bachelor's degree in a technical or scientific field, preferably an engineering discipline
    5 years minimum experience in medical device
    5-10 years minimum in experience in a material or component quality position
    Knowledge of ISO and FDA Quality System Requirements (e.g. ISO 13485; FDA 21 CFR Part 820)
    Demonstrated team leadership skills and ability to prioritize, execute and report on projects
    Experience with engineering tools such as; dFMEA, pFMEA, SPC, etc.
    Working knowledge of process improvement techniques such as Six Sigma, Lean Sigma, Proof of Station, etc.
    Strong project and time management skills
    Demonstrated creative and effective problem solving and original thinking for compliance solutions
    Ability to work on multiple tasks concurrently with changing priorities
    Proficient with of MS Word, Excel and PowerPoint

    Preferred Qualifications
    Master's degree in a technical or scientific field
    Experience in material, component, process and product quality assurance functions
    Experience with 21 CFR 820, ISO 13485, ISO 14971, European Directives and/or Regulations
    Experience with SPC software tools
    Experience with engineering tools such as; DOE, FTA, GHTF requirements for process validations, etc.
    ISO 13485 certified auditor or RAB auditor
    ASQ certifications; CRE, CQM, CQE, CQA etc.
    ISO 14971 training


    Inspire Medical Systems provides equal employment opportunity (EEO) to all employees and applicants without regard to race, color, religion, creed, sex, national origin, age, disability, marital status, familial status, sexual orientation, status regarding public assistance, membership or activity in a local commission, military or veteran status, genetic information, or any other status protected by applicable federal, state, and local laws.

    This policy applies to all aspects of the employment relationship, including recruitment, hiring, compensation, promotion, transfer, disciplinary action, layoff, return from layoff, training, and social and recreational programs.

    Inspire Medical Systems complies with applicable laws governing non-discrimination in employment in every location in which Inspire Medical Systems has facilities.

    All such employment decisions will be made without unlawfully discriminating on any prohibited basis.

    Inspire Medical Systems is an equal opportunity employer with recruitment efforts focused on ensuring a diverse workforce.
    Applicants with a disability that need accommodation to complete the Inspire Medical Systems application process should contact Human Resources at or email

    (dot)com

    Inspire Medical Systems participates in E-Verify.

    #LI-AM1

    #J-18808-Ljbffr
  • Interrad Medical

    Quality Engineer

    1 week ago

    Interrad Medical Plymouth, United States

    Background · Interrad Medical, Inc. is a medical device company located in Plymouth, Minnesota. The company designs, develops and manufactures minimally invasive vascular access implantable medical devices for the US and OUS commercial markets. · The Quality Engineer at Interrad ...

  • Medix

    Quality Engineer

    2 weeks ago

    Medix Minneapolis, United States

    Summary Statement: · Join our dynamic team and play a pivotal role in ensuring the compliance of our Quality Management System (QMS). We're seeking a dedicated individual to collaborate closely with our small team, ensuring adherence to regulatory standards and maintaining the ...

  • Banner Engineering

    Quality Engineer

    1 week ago

    Banner Engineering Minneapolis, United States

    Why Work at Banner? · For over 50 years, Banner Engineering has been at the forefront of some of the biggest industry trends, such as the Industrial Internet of Things (IIoT), and our photoelectric, ultrasonic, and vision sensors, LED lights and indicators, monitoring solutions, ...

  • Dynamic Group

    Quality Engineer

    3 days ago

    Dynamic Group Minneapolis, United States

    Quality EngineerDynamic Group - Ramsey, MNDynamic Group is a premier plastic injection molding and mold building company with two locations in the Northwest suburbs of Minneapolis, MN. We provide medical molded parts in our Ramsey location where production runs on 3 shifts throug ...

  • COGS

    Quality Engineer

    1 week ago

    COGS Minneapolis, United States

    ***QA/QC Manufacturing Engineer*** · $70,000 - $100,000 DOE · We are helping an industry leading & rapidly growing Aerospace Company as they seek to bring on a driven and ambitious QA/QC Manufacturing Engineer to join the expanding engineering and supply chain function. · This ...

  • Saxon Global

    Quality Engineer

    2 days ago

    Saxon Global Minneapolis, United States

    Surest | RemoteETL QE6 Month Contract to Hire Project: The Senior Software Engineer in Quality Engineering will work within Bind's Data Engineering Platform to write automated tests (functional, integration, unit, data quality) in Python to ensure our ETL and data pipeline jobs d ...

  • The Judge Group

    Quality Engineer

    14 hours ago

    The Judge Group Minneapolis, United States

    Our client is currently seeking a Quality Engineer. They are seeking a highly skilled and experienced Quality Engineer to join our team. In this position you will play a key role in maintaining and enhancing the quality standards by developing, implementing, and managing processe ...

  • STERIS

    Quality Engineer

    2 weeks ago

    STERIS Minneapolis, United States

    At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.The Role The Quality Engineer (Supplier) in our Plymouth manufacturing location is responsible for maintaining an ...

  • Interrad Medical

    Quality Engineer

    2 days ago

    Interrad Medical Minneapolis, United States

    Background · Interrad Medical, Inc. is a medical device company located in Plymouth, Minnesota. The company designs, develops and manufactures minimally invasive vascular access implantable medical devices for the US and OUS commercial markets. · The Quality Engineer at Interrad ...

  • Deal Henkilöstöratkaisut Oy

    Quality Engineer

    1 day ago

    Deal Henkilöstöratkaisut Oy Minneapolis, United States

    With more than 2,000 employees at 21 locations worldwide, we are one of the market-leading manufacturers of innovative coating technology. Do-it-yourselfers, craftsmen and industrial customers all over the world trust in our innovative products, resource-saving technologies and o ...

  • Wagner Group

    Quality Engineer

    2 weeks ago

    Wagner Group Minneapolis, United States

    Position Objective: · Assure Wagner Spray Tech manufactured materials conform to specifications set forth in engineering documentation, while operating in the most cost-effective manner. Through active participation, support new product development and sustaining engineering acti ...

  • Wagner Spray Tech

    Quality Engineer

    2 weeks ago

    Wagner Spray Tech Minneapolis, United States

    Job Description · Job Description · Position Objective: · Assure Wagner Spray Tech products conform to specifications set forth in engineering documentation, while operating in the most cost-effective manner. · Through active participation and involvement, lead efforts to supp ...

  • Integer Holdings Corporation

    Quality Engineer

    1 week ago

    Integer Holdings Corporation Minneapolis, United States

    By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success. · At Integer, our values are embedded in everything we do. · Customer · We focus on our customers' su ...

  • Dynamic Group

    Quality Engineer

    1 day ago

    Dynamic Group Minneapolis, United States

    Quality Engineer Dynamic Group Ramsey, MN Dynamic Group is a premier plastic injection molding and mold building company with two locations in the Northwest suburbs of Minneapolis, MN. We provide medical molded parts in our Ramsey location where prod Quality Engineer, Engineer, C ...

  • Spectrum Plastics Master

    Quality Engineer

    3 weeks ago

    Spectrum Plastics Master Minneapolis, United States

    Job Details · Level · Experienced · Job Location · SPG Minneapolis - Minneapolis , MN · Position Type · Full Time · Education Level · 4 Year Degree · Travel Percentage · None · Job Shift · Day · Job Category · QA - Quality Control · Quality Engineer · SUMMARY: · Develop ...

  • Saxon Global

    Quality Engineer

    1 week ago

    Saxon Global Minneapolis, United States

    Surest | Remote · ETL QE · 6 Month Contract to Hire · Project: · The Senior Software Engineer in Quality Engineering will work within Bind's Data Engineering Platform to write automated tests (functional, integration, unit, data quality) in Python to ensure our ETL and data p ...

  • ResourceMFG

    Quality Engineer

    2 weeks ago

    ResourceMFG Minneapolis, United States

    summary Select Staffing has a great opportunity for Quality Engineer within a manufacturing company in Chatsworth, CA. Pay: 60,000-75,000 Salary DOE Responsibilities Provide timely resolution to customer inquiries Returned Material Authorization (RMA) coordination and disposition ...

  • Banner Engineering

    Quality Engineer

    2 weeks ago

    Banner Engineering Minneapolis, United States

    Why Work at Banner?For over 50 years, Banner Engineering has been at the forefront of some of the biggest industry trends, such as the Industrial Internet of Things (IIoT), and our photoelectric, ultrasonic, and vision sensors, LED lights and indicators, monitoring solutions, and ...

  • Integer Holdings Corporation

    Quality Engineer

    1 week ago

    Integer Holdings Corporation Minneapolis, United States

    By living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success. · At Integer, our values are embedded in everything we do. · Customer · We focus on our customers ...

  • COGS

    Quality Engineer

    2 weeks ago

    COGS Minneapolis, United States

    ***QA/QC Manufacturing Engineer***$70,000 - $100,000 DOEWe are helping an industry leading & rapidly growing Aerospace Company as they seek to bring on a driven and ambitious QA/QC Manufacturing Engineer to join the expanding engineering and supply chain function.This opportunity ...