What are the responsibilities and job description for the Quality Systems Specialist I position at Bracco Medical Technologies?
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.
Required Skills
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
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