Senior Specialist, Quality Complaint Investigation

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. 

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 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.
• Complete complex investigations such as Risk Trigger Evaluations and Death/Serious Injury-related investigations

Qualifications

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
• 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.

Education and/or experience

• A Bachelor of Science degree in Engineering
• 3 to 5 years of Medical Device experience

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The minimum salary for this position is €32,000.00 annually. Your initial pay could be at the minimum or higher based on location, skills and expertise, experience, and other relevant factors, all of which are subject to change. This position may also be eligible for competitive benefits, discretionary bonuses, and/or long-term incentive. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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