Lead Quality Assurance Engineer

1 week ago

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

Nuwellis, 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 ensuring Quality representation on teams that drive front-end design, facilitate design transfer to manufacturing, and enhance processes and products. The incumbent is accountable for maintaining product safety and quality throughout all phases of product and process development while ensuring adherence to design specifications, ISO standards, FDA regulations, and other relevant compliance requirements.

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

Key Responsibilities

  • Deliver comprehensive quality engineering support during all design and development stages, in alignment with applicable procedures, regulations, and standards.
  • Review, initiate, and approve change requests related to design verification and validation, risk management, usability, biocompatibility, shelf life, test method validations, equipment qualifications, sterilization, packaging, and labeling.
  • Oversee product development processes and associated procedures.
  • Manage the organization and maintenance of design history files and deliverables.
  • Lead the risk management process in accordance with ISO 14971, including the creation of risk management plans, hazard analyses, FMEAs, and risk management reports throughout product development.
  • Collaborate with R&D and other functional areas to prepare test plans, analyze data, and implement changes.
  • Interpret and contribute to the design and testing of electro-mechanical systems and software.
  • Utilize statistical tools for data analysis, acceptance decisions, and process capability improvements.
  • Identify and apply engineering, technical, and regulatory standards relevant to medical devices.
  • Maintain the Quality System, ensuring compliance with ISO 13485, EU MDR 2017/745, and QSR 21 CFR 820.
  • Assist in managing regulatory inspections and audits from certification/accreditation bodies.
  • Develop quality plans to meet corporate and compliance objectives.
  • Oversee the receiving and final inspection processes.
  • Manage the Material Review Board.
  • Ensure that Corrective Actions are thorough, effective, and timely.
  • Supervise Document and Record Control, Training, CAPA, Change Control, and Feedback and Complaint Systems.
  • Stay informed about existing and emerging regulations, standards, and guidance documents applicable to the industry.
  • Act as a Quality liaison with government agencies and the business community as necessary.
  • Ensure the company maintains readiness for regulatory inspections.
  • Summarize and communicate compliance and feedback information to Senior Management regularly.
  • Oversee supplier quality management to support supplier selection, approval, audits, and CAPA.
  • 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 and/or design assurance.

Preferred Qualifications

  • Master's degree in Engineering or a related discipline.
  • ASQ CQE Certification.
  • 5 years of experience in the medical device sector.
  • 10 years of experience in an FDA or ISO regulated environment.
  • Experience with software design, verification, and validation.
  • Knowledge of biocompatibility, human factors, electrical safety, hardware, and sterilization standards.
  • Proficient in managing risk activities.
  • Experience applying statistical methods to design reliability and process capability.
  • Strong verbal and written communication, analytical, and interpersonal skills.
  • Able to independently devise technical solutions to complex problems.
  • Capable of leading cross-functional teams and contributing effectively.
  • Ability to manage multiple tasks and prioritize effectively.
  • Practical approach to quality with a collaborative style.
  • Proficient in MS Excel, Word, and PowerPoint.

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

    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

    1 week 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

    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 closely with Marketing, Clinical, Regulatory, R&D, and Operations teams,...

  • Lead Quality Assurance Engineer

    1 week 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

    1 week 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

    1 week 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...

  • Senior Quality Assurance Engineer

    12 hours ago

    Eden Prairie, Minnesota, United States UnitedHealth Group Full time

    Job SummaryWe are seeking a highly skilled Senior Quality Assurance Engineer to join our team at UnitedHealth Group. As a key member of our technology team, you will be responsible for designing and implementing test software for software applications, system architectures, and software test tools.Key ResponsibilitiesDesign and implement test software for...

  • 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

    3 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...