Compliance Assurance Engineer

6 days ago

Eden Prairie, Minnesota, United States ShopHQ Full time
Job Title: Product Integrity Specialist

**Job Summary:**

We are seeking a highly skilled Product Integrity Specialist to join our team at ShopHQ. As a key member of our compliance team, you will be responsible for ensuring that our products meet the highest standards of quality and regulatory compliance.

Key Responsibilities:

  • Product Compliance: Interpret policies, procedures, guidelines, and legal and regulatory statutes regarding safety and compliance inquiries and issues.
  • Assess conformity to FDA and FTC requirements for cosmetics, OTC drugs, medical devices, dietary supplements, and food products.
  • Review performance of third-party testing and laboratory analysis including claims substantiation, efficacy testing, safety testing, Safety Data Sheets, and cGMP compliance.
  • Collaborate with cross-functional teams to ensure all required product-specific assets are reviewed in a timely manner and are set up accurately.
  • Collaborate with business teams to ensure compliance with regulatory requirements.

Standards & Practices:

  • Interpret policies, procedures, guidelines, and legal and regulatory statutes regarding safety and compliance inquiries and issues.
  • Perform regular proactive QA audits of products on a test basis, and report results.
  • Draft written and verbal QA policy/process communications for business teams.
  • Manage issues regarding product claims and their substantiation and troubleshoot other advertising issues.
  • Assist in the development of proactive solutions to eliminate or mitigate risks.
  • Review miscellaneous Legal Compliance requests for other product categories.
  • Maintain FDA Food Facility Registration.
  • Refine and implement detailed, technical quality guidelines and evaluation processes.

Cross-functional Team Support:

  • Support vendor onboarding documents in collaboration with Legal and Business teams.
  • Provide regulatory guidance and answer compliance-related questions to cross-functional teams.
  • Provide compliance support for state cause marketing, and FTC/state sweepstakes, contest, and price promotions and other social promotion compliance.
  • Assist in the development of corrective action plans.

Value-added Activities:

  • Perform administrative tasks for Legal Compliance.
  • Educate cross-functional teams on the Standards of Operating Procedures.
  • Continuous professional development to provide thorough compliance-related guidance.

Qualifications / Knowledge, Skills & Abilities:

  • Bachelor's degree or equivalent experience in a related subject matter area.
  • 3-5 years of relevant work experience preferred.
  • 1-2 years of supervisory experience preferred.
  • Ability to define problems, collect data, establish facts, and draw valid conclusions.
  • Effective written and verbal communication skills.
  • Ability to understand technical scientific studies and laboratory analyses.
  • Working knowledge of FTC and FDA laws and regulations as well as all known Federal, state, and local regulations for assigned categories.
  • Ability to manage processes.
  • Self-motivated, timely, reliable, and responsive to time urgent matters.
  • Decision-making, organization, and planning skills.
  • Working knowledge of Microsoft Office Suite.

  • 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

    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 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

    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

    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

    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 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

    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 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...

  • 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...

  • 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 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...

  • 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...

  • Senior Quality Assurance Engineer

    1 day 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 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

    4 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,...

  • 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

    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

    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 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...

  • Compliance and Risk Management Professional

    6 days ago

    Eden Prairie, Minnesota, United States HelpSystems LLC Full time

    About the RoleWe are seeking a highly skilled Security Compliance Analyst to join our team at HelpSystems LLC. As a Security Compliance Analyst, you will play a critical role in ensuring the security and compliance of our organization's systems and processes.Key ResponsibilitiesSecurity and Compliance Support: Provide expert-level support to internal...