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Engineer, Quality Complaint Investigation

1.00 to 10.00 Years   Saudi Arabia   25 Mar, 2022
Baxter
1 Jobs Openings
Job LocationSaudi Arabia
EducationNot Mentioned
SalaryNot Mentioned
IndustryOther Business Support Services
Functional AreaNot Mentioned

Job Description

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. Youll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxters 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. ESSENTIAL FUNCTIONS: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 complaints.
  • Analyze data from various quality inputs (including but not limited to : Field Corrective Action (FCA), Complaints, FDA Medical Device Reports (MDR), etc.) to determining 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.
QUALIFICATIONS, KNOWLEDGE AND SKILLS REQUIRED: To perform this job successfully, and 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)
  • 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.
EDUCTATION/EXPERIENCE REQUIRED:
  • A Bachelors of Science in Engineering
  • 1-3 years of Medical Device experience preferred
The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.Equal Employment OpportunityBaxter 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.                                                                                                                                                               EEO is the Law EEO is the law - Poster Supplement Pay Transparency PolicyReasonable AccommodationsBaxter 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.Recruitment Fraud NoticeBaxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.064570

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