Current jobs related to Quality Assurance Director - Minnesota - X4 Life Sciences

  • Quality Assurance Director

    1 month ago

    Minnesota, United States FPC of Savannah Full time

    Quality Assurance Manager OpportunityWe are seeking a seasoned Quality Assurance Manager to lead our team of QA professionals at our Minnesota plant. As the Site Head for Quality, you will oversee 10-15 manufacturing lines of various oil-based products and ensure compliance with FDA and USDA regulations.This is a fantastic opportunity for a dynamic leader to...

  • Head of Quality Assurance

    2 weeks ago

    minnesota, United States Brunel Full time

    Brunel has been retained to source a Head of Quality Assurance for a leading Minnesota-based, startup client in the Medical Devices space. Click Apply if you might be interested in additional details.Some highlights include:Working on exciting, new technology that has recently gotten a lot of publicity The organization has recently secured additional funding...

  • Head of Quality Assurance

    1 month ago

    minnesota, United States Brunel Full time

    Brunel has been retained to source a Head of Quality Assurance for a leading Minnesota-based, startup client in the Medical Devices space. Click Apply if you might be interested in additional details.Some highlights include:Working on exciting, new technology that has recently gotten a lot of publicity The organization has recently secured additional funding...

  • Head of Quality Assurance

    2 weeks ago

    Minnesota River, Minnesota, USA, United States Brunel Full time

    Brunel is seeking a seasoned Quality Assurance professional to lead the development of quality management systems for a pioneering Medical Devices startup in Minnesota.Some key highlights of this role include:Collaborating with a talented team to drive innovation in new technologyContributing to the organization's growth through strategic quality management...

  • Head of Quality Assurance

    3 weeks ago

    Minnesota River, Minnesota, USA, United States Brunel Full time

    Brunel is seeking a seasoned Head of Quality Assurance to lead the quality management system for a pioneering Minnesota-based medical devices startup. This exciting opportunity offers a chance to work on cutting-edge technology, collaborate with a talented team, and drive impactful results.Some key highlights of this role include:Developing and implementing...

  • Software Quality Assurance Specialist

    1 week ago

    Minnesota, United States Medtronic Full time

    Job SummaryAt Medtronic, we are seeking a seasoned quality professional to join our team as a Quality Assurance and Operations Specialist. This individual will be responsible for working directly with engineering and manufacturing associates to investigate product issues, perform containment on potentially nonconforming product, and document results in...

  • Quality Assurance Specialist

    1 week ago

    Minnesota, United States Aluma Craft Full time

    Key Responsibilities:Read and interpret technical drawings, diagrams, and specifications to determine materials requirements and assembly instructions.Explain assembly procedures and techniques to colleagues.Perform visual inspections of finished products to ensure quality standards are met.Identify and troubleshoot equipment problems to minimize...

  • Quality Improvement Risk Manager

    1 month ago

    Minnesota, United States Sevita Full time

    Job Title: Quality Improvement Risk ManagerAt Sevita, we are committed to providing comprehensive in-home, center-based, and school-based skilled therapy services for infants, children, and young adults. As a Quality Improvement Risk Manager, you will play a critical role in ensuring the highest level of quality and safety in our services.Key...

  • Quality Assurance Specialist IV

    1 month ago

    Minnesota, United States Medtronic Full time

    Quality Technician IVAt Medtronic, we're pushing the boundaries of what technology can do to make tomorrow better than yesterday. As a Quality Technician IV, you'll play a critical role in ensuring the quality of our life-restoring therapies and healthcare solutions.Key Responsibilities:Execute product inspection and test plans on bio-hazard...

  • Program Director for Behavioral Health Services

    7 days ago

    Minnesota, United States Catholic Charities Full time

    Job SummaryCatholic Charities seeks a highly skilled and experienced Director of Behavioral Health Services to lead our Behavioral Health programs. The successful candidate will be responsible for establishing, monitoring, and reviewing program objectives, performance-based standards, and strategic plans.Key ResponsibilitiesOversee the management and...

  • Quality and Regulatory Manager

    2 weeks ago

    Minnesota, United States Belimed Full time

    Job Title: Quality and Regulatory ManagerBelimed is a leading supplier of medical and surgical instrument sterilization, disinfection, and cleaning products and services. We are headquartered in Zug, Switzerland, and have a strong presence in the global market.Your Key Responsibilities:Implement and maintain quality control and quality assurance processes...

  • Assistant Salon Director

    7 days ago

    Minnesota, United States Sun Tan City Full time

    **Drive Store Performance**The Assistant Salon Director plays a crucial role in driving store performance, fostering superior client service, and maintaining operational excellence to meet or exceed established productivity goals.This individual will manage and supervise Tanning Consultants to achieve company goals and lead by example in all company...

  • Supplier Development Engineer

    6 days ago

    Minnesota, United States New Flyer Full time

    Job SummaryThe Supplier Development Engineer is responsible for driving supplier performance improvement at NFI Group. This role involves working closely with suppliers to enhance their quality and delivery capabilities, ensuring they meet the highest standards of excellence.Key ResponsibilitiesDevelop and implement supplier quality improvement plans to...

  • Evening Nurse Supervisor RN

    7 days ago

    Minnesota, United States Eden Senior Care Full time

    At Eden Senior Care, we are seeking a dedicated and experienced Evening Nurse Supervisor to join our team at Edenbrook St Cloud, a skilled nursing facility located in St Cloud, Minnesota. As a key member of our nursing department, you will be responsible for ensuring the quality of care and services provided to our residents.Main Responsibilities:Ensuring...

  • Physician - Occupational Medicine Medical Director

    2 months ago

    Minnesota, United States Integrity Healthcare. Full time

    Job SummaryWe are seeking an experienced Occupational Medicine Physician to lead our clinic as Medical Director. As a key member of our team, you will be responsible for providing clinical leadership and direction to our healthcare professionals, while also contributing to the development and implementation of our occupational medicine programs.Key...

  • Operations Director

    1 month ago

    Minnesota, United States Gable Search Group Full time

    Operations Manager Job DescriptionGable Search Group is seeking an experienced Operations Manager to lead a 24x7 production team at a central Minnesota manufacturing facility. The ideal candidate will have a strong background in food processing and manufacturing operations, with a proven track record of developing effective and efficient teams.Key...

  • Operations Director

    2 weeks ago

    Minnesota, United States Gable Search Group Full time

    Job Title: Operations ManagerOur Fortune 200 dairy client is seeking an experienced Operations Manager to lead a central Minnesota manufacturing facility near St. Cloud. This key position will report to the Plant Manager and oversee a 24x7 operation, mentoring, coaching, and training team members to develop effective and efficient teams. Collaborates with...

  • Operations Director

    2 months ago

    Minnesota, United States Gable Search Group Full time

    Operations Manager Job DescriptionGable Search Group is seeking an experienced Operations Manager to lead our client's central Minnesota manufacturing facility near St. Cloud. This key position will report to the Plant Manager and oversee a 24x7 operation, mentoring, coaching, and training team members to develop effective and efficient teams.The successful...

  • Program Director

    3 weeks ago

    Fergus Falls, MN, Otter Tail County, MN; Minnesota, United States Sevita Full time

    REM Community Services , a part of the Sevita family, provides community-based services for individuals with intellectual and developmental disabilities. Here we believe every person has the right to live well, and everyone deserves to have a fulfilling career. You’ll join a mission-driven team and create relationships that motivate us all every day....

  • Ethanol Production Facility Director

    4 weeks ago

    Minnesota, United States Allied Executive Staffing Full time

    Plant Manager - Ethanol Production FacilityOur client, a leading global player in the Ethanol and Biofuel industry, is seeking an experienced Plant Manager to oversee the daily operations of their ethanol production facility.Key Responsibilities:Lead and manage a team of production supervisors, engineers, and plant operators to ensure efficient production,...

Quality Assurance Director

2 months ago

Minnesota, United States X4 Life Sciences Full time

Quality Assurance Director

X4 Life Sciences is committed to enhancing patient outcomes through innovative technology and superior products. In the role of Quality Assurance Director, you will be instrumental in guaranteeing the quality, safety, and regulatory compliance of diagnostic and software-based medical devices. This strategic leadership position involves directing the Quality Assurance (QA) team, spearheading continuous improvement efforts, and ensuring our offerings adhere to both internal benchmarks and regulatory standards.

Key Responsibilities:

  • Oversee QA Operations: Manage all quality assurance functions, including the establishment and upkeep of Quality Management Systems (QMS) that comply with FDA, ISO, and international standards.
  • Ensure Regulatory Adherence: Confirm that all products meet applicable regulations, including FDA (21 CFR Part 820 and 11), ISO 13485, ISO 14971, and international standards such as EU MDR/IVDR.
  • Manage Product Lifecycle: Navigate products through every phase of their lifecycle, from design and development to regulatory approval and post-market monitoring.
  • Lead and Develop Teams: Supervise and mentor the QA team, promoting a culture centered on quality and ongoing enhancement.
  • Collaborate Across Functions: Partner closely with R&D, Regulatory Affairs, Manufacturing, and other divisions to ensure comprehensive product quality and compliance.
  • Implement Risk Management: Direct risk management activities in line with ISO 14971, ensuring that potential risks are identified and addressed effectively.

Qualifications:

  • Professional Experience: Over 10 years in Quality Assurance within the medical device sector, particularly in diagnostics and software-driven solutions.
  • Regulatory Expertise: In-depth knowledge of FDA regulations, ISO standards, and global regulatory frameworks.
  • Leadership Skills: Demonstrated ability to lead and cultivate QA teams, with a history of implementing continuous improvement strategies.
  • Educational Background: Bachelor's or Master's degree in Engineering, Life Sciences, or a related discipline. Advanced certifications in Quality Assurance or Regulatory Affairs are advantageous.
  • Core Competencies: Exceptional communication and leadership abilities, with a proven capacity to thrive in a dynamic, collaborative environment.