Quality Operations Investigation Specialist
Baxter
Medolla, Emilia-Romagna, Italy
2 gg fa

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world.

You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives where your purpose accelerates our mission.

Summary

Covering this role, you’ll be accountable for activities related to complaints and nonconformities technical investigation, according to applicable procedures.

I’ll report to the Qa Ops Investigation Supervisor and you’ll collaborate with a team that supports our mission : Save and Sustain Lives.

Essential Duties and Responsibilities

  • Performs activities related to investigation of customer complaints and manufacturing nonconformances in order to find the root causes of events, according to applicable procedures;
  • Coordinates complex root cause analysis activities and provide support to the investigation team, ensuring that activities are conducted with appropriate scientific methods and following a DMAIC approach;
  • Develops and implements experiments and tests to confirm or rule out potential root causes, demonstrating knowledge id Design Of Experiments (DOE) and statistical analysis;
  • Writes investigations reports in order to properly document the activities in accordance with good documentation practices (GDP);
  • Manages critical quality issues and keeps track of their resolution processes, interfacing with subject matter experts from different areas and, when required, leading the investigation teams;
  • Supports his supervisor in order to identify the immediate, corrective and preventive actions as per continuous improvement process;
  • Supports in case of audits;
  • Escalates to the quality site management and to senior managers relevant and critical quality issues;
  • Qualifications

  • Degree in Engineering (biomedical, electronical, mechanical );
  • 4-5 years of experience in Quality area in the medical industry or other fields;
  • Knowledge of principles of dialysis / hemodialysis products;
  • Previous experience in Project Management will be considered a plus;
  • Organization skills and ability to do multiple tasks at once;
  • Good communication and interpersonal skills;
  • Problem Solving attitude;
  • Fluent in English.
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