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
**Compensation & Total Rewards: **
Estimated Starting Salary Range: $72,000.00 – $78,000.00
*Estimated Starting Salary Range is reflective of the range Bracco Medical Technologies reasonably expects to pay for the position. The range provided is based on salary and market data specific to the position.
Total Rewards:
Bracco Medical Technologies is an Affirmative Action/Equal Opportunity Employer. Bracco Medical Technologies desires priority referrals of protected veterans for all openings.
Required Experience
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
**Compensation & Total Rewards: **
Estimated Starting Salary Range: $72,000.00 – $78,000.00
*Estimated Starting Salary Range is reflective of the range Bracco Medical Technologies reasonably expects to pay for the position. The range provided is based on salary and market data specific to the position.
Total Rewards:
Bracco Medical Technologies is an Affirmative Action/Equal Opportunity Employer. Bracco Medical Technologies desires priority referrals of protected veterans for all openings.