Lead Quality Assurance Engineer

2 weeks ago

Eden Prairie, Minnesota, United States Nuwellis, Inc. Full time
Job Overview

Nuwellis, Inc. is a pioneering medical device organization committed to enhancing the quality of life for patients experiencing fluid overload through its innovative Aquadex SmartFlow ultrafiltration therapy.

The Principal Design Assurance & Quality Engineer collaborates closely with Marketing, Clinical, Regulatory, R&D, and Operations teams, ensuring robust Quality representation throughout the product lifecycle. This role is pivotal in safeguarding product safety and quality during all phases of product and process development, while also ensuring adherence to design specifications, ISO standards, FDA regulations, and other relevant compliance requirements.

This position necessitates a full-time, onsite presence at Nuwellis' corporate office.

Key Responsibilities

  • Deliver comprehensive quality engineering support throughout the design and development phases, adhering to all relevant procedures, regulations, and standards.
  • Review, initiate, and approve change requests related to design verification & validation, risk management, usability, biocompatibility, shelf life, and more.
  • Oversee product development processes and maintain associated documentation.
  • Manage the organization and maintenance of design history files.
  • Implement and manage the risk management process in line with ISO 14971, including the creation of risk management plans and hazard analyses.
  • Collaborate with R&D and other functional areas on test plans, data analysis, and change implementation.
  • Contribute to the design and testing of electro-mechanical systems and software.
  • Utilize statistical tools for data analysis and process improvement.
  • Ensure compliance with ISO 13485, EU MDR 2017/745, and QSR 21 CFR 820.
  • Assist in managing regulatory inspections and audits.
  • Develop quality plans to meet corporate and compliance objectives.
  • Oversee the receiving and final inspection processes.
  • Ensure effective corrective actions are implemented in a timely manner.
  • Maintain a thorough understanding of current and emerging regulations and standards applicable to the medical device industry.
  • Act as a liaison with regulatory agencies and the business community.
  • Support supplier quality management through selection, approval, and audits.
  • Identify quality trends and propose strategies to enhance overall quality performance.

Qualifications

  • Bachelor's degree in Engineering or a related field.
  • A minimum of 10 years of experience in quality assurance or design assurance.

Preferred Qualifications

  • Master's degree in Engineering or a related discipline.
  • ASQ CQE Certification.
  • Experience in the medical device sector.
  • Extensive experience in FDA or ISO regulated environments.
  • Knowledge of software design, verification, and validation processes.
  • Experience with biocompatibility and electrical safety standards.
  • Strong analytical and communication skills.
  • Ability to work collaboratively across functions and manage multiple projects effectively.

Equal Opportunity Employer: minority/female/disability/veteran

  • Lead Quality Assurance Engineer

    2 weeks ago

    Eden Prairie, Minnesota, United States Jobot Full time

    Tier 1 OEM seeks Lead Quality Assurance Engineer to enhance our quality initiatives. This Jobot Job is hosted by: Ryan Purdy Salary: $100,000 - $130,000 per year About Us: A premier Tier 1 OEM automotive manufacturer with a rich legacy. Why Work With Us? Competitive compensation Positive work environment Comprehensive benefits Growth opportunities ...

  • Lead Quality Assurance Engineer

    2 weeks ago

    Eden Prairie, Minnesota, United States Jobot Full time

    Overview: A prominent Tier 1 OEM is in search of a Lead Quality Assurance Engineer to enhance their expanding team.About the Role: As a Lead Quality Assurance Engineer, you will play a pivotal role in steering our quality assurance initiatives, ensuring that our production processes adhere to and surpass the highest quality benchmarks.Key...

  • Lead Quality Assurance Engineer

    1 week ago

    Eden Prairie, Minnesota, United States Jobot Full time

    Join a Leading Tier 1 OEM as a Lead Quality Assurance Engineer.This Jobot Job is hosted by: Ryan PurdyAre you a fit? Easy Apply now by clicking the "Apply Now" buttonand sending us your resume.Salary: $100,000 - $130,000 per yearAbout Us:We are a prominent Tier 1 OEM automotive manufacturer with a legacy of excellence.Why Work With Us?Attractive...

  • Lead Quality Assurance Engineer

    2 weeks ago

    Eden Prairie, Minnesota, United States Nuwellis, Inc. Full time

    Job OverviewNuwellis, Inc. is a pioneering medical device organization committed to enhancing the quality of life for patients experiencing fluid overload through its innovative Aquadex SmartFlow ultrafiltration therapy.The Principal Design Assurance & Quality Engineer collaborates with various departments including Marketing, Clinical, Regulatory, R&D, and...

  • Lead Quality Assurance Engineer

    7 days ago

    Eden Prairie, Minnesota, United States Nuwellis, Inc. Full time

    Job OverviewNuwellis, Inc. is a pioneering medical device organization focused on enhancing the quality of life for patients experiencing fluid overload through innovative therapies.The Principal Design Assurance & Quality Engineer collaborates with various departments including Marketing, Clinical, Regulatory, R&D, and Operations. This role is crucial in...

  • Lead Quality Assurance Engineer

    2 weeks ago

    Eden Prairie, Minnesota, United States Nuwellis, Inc. Full time

    Job OverviewNuwellis, Inc. is a pioneering medical device organization focused on enhancing the quality of life for patients experiencing fluid overload through its innovative Aquadex SmartFlow ultrafiltration therapy.The Principal Design Assurance & Quality Engineer collaborates closely with various departments including Marketing, Clinical, Regulatory,...

  • Lead Quality Assurance Engineer

    7 days ago

    Eden Prairie, Minnesota, United States Nuwellis, Inc. Full time

    Job OverviewNuwellis, Inc. is a pioneering medical device organization committed to enhancing the lives of individuals experiencing fluid overload through its innovative Aquadex SmartFlow ultrafiltration therapy.The Principal Design Assurance & Quality Engineer collaborates closely with Marketing, Clinical, Regulatory, R&D, and Operations teams, taking on...

  • Lead Quality Assurance Engineer

    7 days ago

    Eden Prairie, Minnesota, United States Nuwellis, Inc. Full time

    Job OverviewNuwellis, Inc. is a pioneering medical device organization focused on enhancing the lives of patients dealing with fluid overload through its innovative Aquadex SmartFlow ultrafiltration therapy.The Principal Design Assurance & Quality Engineer collaborates with various departments including Marketing, Clinical, Regulatory, R&D, and Operations....

  • Lead Software Quality Assurance Engineer

    2 weeks ago

    Eden Prairie, Minnesota, United States ACIST Medical Systems Full time

    Why Join ACIST Medical Systems?At ACIST Medical Systems, we are dedicated to making a difference in healthcare through innovative medical technologies. Our advanced medical devices provide healthcare professionals with the essential tools to make informed and timely decisions for patient care.Position Overview:The Lead Software Quality Assurance Engineer is...

  • Lead Quality Assurance Engineer

    7 days ago

    Eden Prairie, Minnesota, United States Nuwellis, Inc. Full time

    Job OverviewNuwellis, Inc. is a pioneering medical device organization committed to enhancing the lives of patients experiencing fluid overload through its innovative Aquadex SmartFlow ultrafiltration therapy.This senior-level Quality Engineer role encompasses various components of the Quality Management System, focusing on product and process quality,...

  • Lead Quality Assurance Engineer

    7 days ago

    Eden Prairie, Minnesota, United States Nuwellis, Inc. Full time

    Job OverviewNuwellis, Inc. is a pioneering medical device organization committed to enhancing the lives of patients experiencing fluid overload through its innovative Aquadex SmartFlow ultrafiltration therapy.This senior-level Quality Engineer role encompasses various facets of the Quality Management System, focusing on product/process quality, supplier...

  • Lead Quality Assurance Engineer

    2 weeks ago

    Eden Prairie, Minnesota, United States Nuwellis, Inc. Full time

    Job OverviewNuwellis, Inc. is a pioneering medical device organization committed to enhancing the lives of patients dealing with fluid overload through its innovative Aquadex SmartFlow ultrafiltration therapy.This senior-level Quality Engineer role encompasses various facets of the Quality Management System, focusing on product and process quality, supplier...

  • Quality Assurance Engineer

    2 weeks ago

    Eden Prairie, Minnesota, United States Beacon EmbeddedWorks Full time

    Position OverviewROLE SUMMARYThe Quality Assurance Engineer is responsible for delivering technical support and manufacturing assistance across all facets of product and process quality. This includes conducting root cause investigations, gathering data, and formulating plans for incoming quality assurance.Reporting Structure: Reports to the Senior Manager...

  • Quality Assurance Specialist

    2 weeks ago

    Eden Prairie, Minnesota, United States Stratasys Full time

    Quality Assurance SpecialistLocation: Eden Prairie, MN, USJob ID: 53740Category: Manufacturing & OperationsAbout Stratasys:Stratasys stands at the forefront of 3D printing technology, driving the global transition to additive manufacturing. Our innovative solutions cater to diverse sectors including aerospace, automotive, consumer goods, and healthcare. By...

  • Quality Assurance Engineer

    2 weeks ago

    Eden Prairie, Minnesota, United States Beacon EmbeddedWorks Full time

    CORPORATE OVERVIEW The Organization Beacon EmbeddedWorks is a comprehensive provider of embedded solutions. Its cutting-edge System on Modules (SOMs) are supported by a broad range of customization, security, and support services, with a dedicated team of specialists offering in-house manufacturing and assistance to expedite development and mitigate risks....

  • Quality Assurance Specialist

    2 days ago

    Eden Prairie, Minnesota, United States Aludec Full time

    Job SummaryWe are seeking a highly skilled and detail-oriented Quality Assurance Specialist to join our team at Aludec. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality of our products and services.Key ResponsibilitiesProvide cosmetic quality guidance to production operators using approved standard cosmetic gauges,...

  • Sr. Design Assurance Engineer

    1 month ago

    Eden Prairie, Minnesota, United States Bracco Medical Technologies Full time

    Sr. Design Assurance EngineerLinkedIn Twitter Email Message ShareWhy Join Bracco Medical Technologies?At Bracco Medical Technologies, every employee has an impact on our Mission to empower lifesavingdecisions. We create medical devices that give healthcare providers theinsights they need to confidently and safely diagnose patients. Our unique lineof products...

  • Quality Assurance Specialist

    2 weeks ago

    Eden Prairie, Minnesota, United States Moffat Workforce Full time

    Quality Assurance Specialist – Direct HireCompany: Moffat WorkforceWe are seeking a qualified candidate to join our team as a Quality Assurance Specialist. The ideal applicant will possess a minimum of 2 years of experience in quality assurance within the medical device industry, along with a solid grasp of ISO 13485 standards.Key Responsibilities:Execute...

  • Senior Quality Engineering Manager

    2 weeks ago

    Eden Prairie, Minnesota, United States UnitedHealth Group Full time

    Position Overview:The Senior Manager of Quality Engineering is responsible for enhancing the quality engineering capabilities and deliverables within the organization. This role involves preparing the team for cloud integration and DevOps methodologies while ensuring strict oversight of project outcomes, quality metrics, and financial controls.Key...

  • Senior Quality Engineering Manager

    2 weeks ago

    Eden Prairie, Minnesota, United States UnitedHealth Group Full time

    Position Overview:The Senior Manager of Quality Engineering is pivotal in enhancing the quality assurance function and its deliverables. This role is essential for preparing the team for cloud and DevOps environments while ensuring stringent control over project deliverables, quality metrics, and financial oversight.Key Responsibilities:Advance the Quality...