Quality Systems Specialist I

2 months ago

Eden Prairie, United States Bracco Medical Technologies Full time
Quality Systems Specialist I LinkedIn Twitter Email Message Share
Why Join Bracco Medical Technologies?

At Bracco Medical Technologies, every employee has an impact on our Mission to empower lifesaving decisions. We create medical devices that give healthcare providers the insights they need to confidently and safely diagnose patients. Our unique line of products includes Intravascular Ultrasound (IVUS), Fractional Flow Reserve (FFR), Cardiovascular Imaging contrast delivery (CVi), and CT and MRI contrast delivery systems.


Position Description Position Summary: The Quality System Specialist I is responsible for supporting the maintenance of the ACIST/Bracco Medical Technologies (BMT) Quality Management System. The Quality Assurance Specialist will support development of a robust quality system in compliance with all relevant standards and regulations at ACIST/BMT. Primary Duties & Responsibilities: Quality Management System Support: * Initiate, facilitate and/or manage projects to expand, change, enhance, and improve the quality system, as assigned; * Create, review, and maintain quality system SOPs, work instructions, and other documents as assigned; * Support Notified Body audits, customer/partner audits, and FDA inspections. * Participate on project teams as assigned. Document Management: * Process change orders to ensure timely and accurate completion, including updates to ERP system; * Ensure released documentation is appropriately filed and all documents sent to required external organizations and verified as received; * File, scan, and facilitate electronic storage of Device History Records, and/or compile, ship, and review records sent to third-party for storage; * Provide training, guidance, and customer support to Documentation System users; * Work autonomously and resolve technical issues; Employee Training * Administer the learning management system by assigning training in the Learning Management System (LMS) * Enter employee training requirements in the LMS; * Create online courses in the LMS; * Assign required employees to take online courses in the LMS; * Run reports as required from the LMS and audit for accuracy.


Qualifications (Knowledge, Skills & Abilities): Minimum * Bachelor's degree plus 1-3 years experience or, in lieu of degree, a High School Diploma or equivalent plus minimum of 5 years experience in Quality Assurance or Document Control role in a medical device manufacturing environment. * Medical device and/or pharmaceutical industry experience, * Beginning Knowledge of ISO 13485 and other Quality System regulations (e.g., FDA Quality System Regulation and EU MDD/MDR) * Microsoft Office experience * Strong interpersonal and communication skills * Familiar with manufacturing shop order controls and engineering change orders * Familiar with inventory MRP/ERP systems, such as SAP * Seeks information when something is not clear * Understands importance of procedural and Quality System compliance * Good organizational skills * Familiar with Good Documentation Practices (GDP) Preferred: * Medical Device Quality System experience in an FDA-regulated environment; * Experience administering engineering change orders for a Medical Device manufacturer; Other: * Mental demands - work is detail oriented, often with multiple priorities. The environment is deadline sensitive and may be exposed to high-pressure situations.


Job Location 7905 Fuller Road, Eden Prairie, Minnesota
Tracking Code 1282-432
ACIST Medical is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

  • Quality Systems Specialist I

    2 months ago

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

    Quality Systems Specialist ILinkedIn 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...

  • Product Quality Technician I

    2 months ago

    Eden Prairie, United States ACIST Medical Systems Full time

    Product Quality Technician I LinkedIn Twitter Email Message Share Why Join Bracco Medical Technologies? At Bracco Medical Technologies, every employee has an impact on our Mission to empower lifesaving decisions. We create medical devices that give healthcare providers the insights they need to confidently and safely diagnose patients. Our unique line of...

  • Quality Assurance Inspector I

    6 days ago

    Eden Prairie, United States Nuwellis, Inc Full time

    Job Type Full-time Description Nuwellis, Inc. is a medical device company dedicated to transforming the lives of patients suffering from fluid overload with its Aquadex SmartFlow ultrafiltration therapy. The Quality Assurance Inspector I / Assembler I position supports both the Quality and Operations Departments (50% time in each department). The Quality...

  • Quality Assurance Inspector I

    3 weeks ago

    Eden Prairie, United States Nuwellis, Inc. Full time

    Job DescriptionJob DescriptionDescription:Nuwellis, Inc. is a medical device company dedicated to transforming the lives of patients suffering from fluid overload with its Aquadex SmartFlow ultrafiltration therapy.The Quality Assurance Inspector I / Assembler I position supports both the Quality and Operations Departments (50% time in each department).The...

  • Quality Control Specialist

    6 days ago

    Grand Prairie, Texas, United States First Assured Quality Systems LLC Full time

    About First Assured Quality Systems LLC First Assured Quality Systems LLC is a leading provider of quality assurance services to diverse industries. We are committed to delivering exceptional service and exceeding client expectations through our expertise, innovation, and dedication to excellence. Job Summary We are seeking a highly motivated and...

  • Quality Assurance Specialist

    7 days 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...

  • Product Quality Technician I

    2 months ago

    Eden Prairie, United States Bracco Medical Technologies Full time

    Product Quality Technician I LinkedIn Twitter Email Message Share Why Join Bracco Medical Technologies?At Bracco Medical Technologies, every employee has an impact on our Mission to empower lifesaving decisions. We create medical devices that give healthcare providers the insights they need to...

  • Product Quality Technician I

    6 days ago

    Eden Prairie, United States Bracco Medical Technologies Full time

    Product Quality Technician ILinkedIn Twitter Email Message ShareWhy Join Bracco Medical Technologies? At Bracco Medical Technologies, every employee has an impact on our Mission to empower lifesaving decisions. We create medical devices that give healthcare providers the insights they need to confidently and safely diagnose patients. Our unique line of...

  • Systems Administrator I

    2 months ago

    Eden Prairie, Minnesota, United States MRA-The Management Association Full time

    Ready Credit CorporationSystems Administrator IEden Prairie, MNHybrid RoleFor over 16 years, Ready Credit has worked to simplify and secure the payment experience for both clients and customers through fully cashless operations. Ready Credit was founded in Minneapolis, Minnesota on the premise that all businesses can benefit from getting rid of cash but only...

  • Mechanical Systems Assembly Specialist

    7 days ago

    Eden Prairie, Minnesota, United States Illinois Tool Works Full time

    Join Illinois Tool Works as a Mechanical Systems Assembly SpecialistAbout Us:At Illinois Tool Works, we foster a culture of innovation and growth. Our team is comprised of talented individuals who are dedicated to making a significant impact through their work.Your Role:As a Mechanical Systems Assembly Specialist, you will be responsible for assembling and...

  • Quality Assurance Systems Specialist

    6 days ago

    Grand Prairie, Texas, United States Indorama Ventures Sustainable Recycling Full time

    Job OverviewQuality Assurance Systems Specialist Summary: The Quality Assurance Systems Specialist will play a pivotal role in spearheading the creation and execution of ISO certifications from inception. This position is essential for establishing a comprehensive quality management framework (QMF) that adheres to ISO standards, ensuring regulatory...

  • Supply Chain Analyst I

    2 months ago

    Eden Prairie, United States ACIST Medical Systems Full time

    Job Description Position Summary: The Supply Chain Analyst I is responsible for ensuring that key Supply Chain data is reliable, meaningful and easily accessible to ensure timely, accurate and fact-based decision making. This role supports all activities relating to Supply Chain functions including, but not limited to: collecting and analyzing data and...

  • Supply Chain Analyst I

    1 month ago

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

    Job DescriptionPosition Summary:The Supply Chain Analyst I is responsible for ensuring that key Supply Chain data is reliable, meaningful and easily accessible to ensure timely, accurate and fact-based decision making. This role supports all activities relating to Supply Chain functions including, but not limited to: collecting and analyzing data and trends,...

  • IT Systems Specialist

    1 day ago

    Eden Prairie, Minnesota, United States The ABK Group, LLC Full time

    POSITION: IT Systems SpecialistLOCATION: Hybrid Work EnvironmentWORK SCHEDULE: 3 days in-office per weekEMPLOYMENT TYPE: Direct Hire or Contract to HireKEY RESPONSIBILITIES:Server Management:Accountable for the installation, maintenance, and upgrades of Windows servers.Ensures optimal server performance through continuous monitoring, configuration,...

  • Quality Engineer

    3 months ago

    Eden Prairie, United States Phillips & Temro Industries Full time

    Description POSITION SUMMARY: Provides Quality Engineering leadership and support in safety, new product and process introductions, process and product improvements and problem solving to drive continuous improvement in the assigned area. Acts as a technical resource to address issues that impact product quality and customer satisfaction. ESSENTIAL DUTIES...

  • Quality Assurance Specialist

    6 days 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 Retail Specialist

    2 months ago

    Eden Prairie, United States Lunds & Byerlys Full time

    Job DescriptionJob DescriptionOur Commitment to You: Lunds & Byerlys is committed to taking care of the employees who take care of our customers. We are committed to creating work environments centered around the values of hospitality, teamwork, and opportunity. Lunds & Byerlys is committed to providing equal opportunities to all interested and qualified...

  • Quality Engineer

    2 months ago

    Eden Prairie, United States Phillips & Temro Industries Full time

    Description POSITION SUMMARY: Under the direction of the Engineering Manager or designate; provide Quality Engineering leadership and support in safety, new product and process introductions, process and product improvements and problem solving to drive continuous improvement for Phillips and Temro and EVoCharge. Acts as a technical resource to address...

  • Audio-Visual Support Specialist

    7 days ago

    Eden Prairie, Minnesota, United States AVI Systems Full time

    Location: Minneapolis, MNCompany Overview:At AVI Systems, we are driven by our passion for technology. Our mission is to design and integrate state-of-the-art solutions for our diverse clientele across various sectors including business, government, healthcare, education, and entertainment.Position Summary:We are currently looking for an Audio-Visual Support...

  • Senior Systems Engineer

    1 month ago

    Eden Prairie, United States ACIST Medical Systems Full time

    Job Description The Senior Systems Engineer position is a key technical leadership role at BMT and has responsibility for the design ownership of a single product over the full lifecycle. In this role, the System Engineer will integrate multi-disciplinary inputs and outputs to support the definition and development of complex software-controlled...