Job Information
ACIST Medical Systems Quality Systems Specialist I in Eden Prairie, Minnesota
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 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 Medical Systems. 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. 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 will be considered * 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 1346-432 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.
