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Baxter Logo Baxter · Quality Control

Specialist, Quality Complaint Investigation

Malta, San Ġwann tal-Għargħar, San Ġwann Employment contract 27200.00 EUR / Year · Job Posted June 15, 2026
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Job Description

This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.

Job Responsibility

  • Investigation, review, and completion of all Quality Engineering complaint issue analysis tasks utilizing various quality system inputs
  • Review individual complaints and associated service data to determine risk level and complete investigation into the as determined problem code and cause codes for each complaint
  • Analyze data from various quality inputs (including but not limited to: Field Corrective Action (FCA), Complaints, FDA Medical Device Reports (MDR), etc.) to determine trends and systemic issues
  • Prepare and issue reports based on information analysis
  • Review existing investigation reports and identify gaps for GMP compliance
  • Develop strategies and plans to close the gaps in an efficient and technical manner
  • Develop and communicate expectations for quality performance, continuous improvement and process controls for marketed products
  • Monitor and drive corrective action and continuous improvement activities that directly impact performance measures by performing primary investigations, conducting data analysis, and implementing corrective actions
  • Conduct or lead corrective and preventive actions in manufacturing using formal problem-solving tools and documentation
  • Support CAPA and maintenance activities for existing product lines
  • Recommend and/or support projects for improvements to the quality system as approved by management

Requirements

  • Medical Device Experience with knowledge of 21CFR820 preferred
  • Investigational research skills
  • Experience with any statistical software packages (Minitab a plus)
  • Desired experience in the medical device industry in the development and deployment of Quality Systems, and process controls, and continuous improvement methods
  • Knowledge and working application of FDA cGMP
  • ANSI/ISO/ASQC requirements
  • CMDAS (optional)
  • Knowledge and working application of reading and understanding blueprints and technical drawings
  • Demonstrated strong analytical problem solving (Root Cause Investigations
  • Display a solid technical understanding of engineering principles and procedures (e.g. CAD and its application or scheduling a series of technical tasks utilizing software-based tools)
  • Computer competency in Word, Excel, Power Point, Minitab, Access and databases
  • Ability to multi-task and methodically manage projects
  • A Bachelor's degree in Engineering
  • 1-3 years of Medical Device experience

Nice to have

  • Medical Device Experience with knowledge of 21CFR820 preferred
  • Experience with any statistical software packages (Minitab a plus)
  • CMDAS (optional)

What we offer

  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer
  • competitive benefits
  • discretionary bonuses
  • long-term incentive
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