Baxter

Healthcare

Specialist,QualityComplaintInvestigation

Malta FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Junior candidates.

The Brief

“Specialist, Quality Complaint Investigation at Baxter. Skills: Quality Complaint Investigation, Root Cause Investigations, data analysis, CAPA, Medical Device Experience. Investigation, review, and completion of all Quality Engineering complaint issue analysis tasks utilizing various quality system inputs. Analyze data from various quality inputs to determine trends and systemic issues. Develop strategies and plans to close gaps in an efficient and technical manner. Develop and communicate expec”

What You'll Achieve.

We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Industry & Context.

Healthcare
Problems you'll solve

Root Cause Investigations; problem-solving tools; analytical problem solving

Eligibility Requirements

This position has primary responsibility for investigation, review, and completion of all Quality Engineering complaint issue analysis tasks utilizing various quality system inputs.

What They're Looking For.

Must Have

A Bachelor’s degree in Engineering. 1-3 years of Medical Device experience. Investigational research skills. Demonstrated 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.

Nice to Have

Medical Device Experience with knowledge of 21CFR820 preferred. 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 ANSI/ISO/ASQC CMDAS (optional).

What You'll Do.

Investigation, review, and completion of all Quality Engineering complaint issue analysis tasks utilizing various quality system inputs.

Analyze data from various quality inputs to determine trends and systemic issues.

Develop strategies and plans to close 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.

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.

How You'll Work.

Team & Collaboration

Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration.

Communication Scope

communicate expectations

Process & Methodology

methodically manage projects

Full Job Description

**This is where** your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. Now we are looking for a Quality Complaint Investigation Specialist to join our team in Malta. **Essential duties and Responsibilities:** This position has primary responsibility for 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 d

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