• Engineer , Quality Complaint Investigation V Jobs in United States Of America

  • Baxter India Pvt Ltd
  • United States Of America, Usa
  • Save Job
  • 1 - 3 Years
  • Posted : above 1 month

Job Description:

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)
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 blue prints and technical drawings
Demonstrated strong analytical problem solving (Root Cause Investigations
Display a solid technical understanding of engineering principles and procedures (eg 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

V PHYSICAL DEMANDS Able to exert up to 10 pounds of force occasionally
Able to sit, stand, walk throughout the work day

VIWORK ENVIRONMENT Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of the job Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

Baxter is a manufacturing environment regulated by the FDA and many other work rules to prevent damage to the product we manufacture Some of those work rules include but are not limited to

Wearing a static protective smock at all times while in the work area
Working in close proximity to other employees
Working in an environment that is temperature and humidity controlled

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

EEO is the Law
EEO is the law - Poster Supplement

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Healthcare
Functional Area : Production/Manufacturing/Maintenance/Packaging
Role : Production/Manufacturi ng/Maintenance
Salary : As per Industry Standards
Deadline : 19th Feb 2020

Key Skills:

Company Profile:

Company
Baxter India Pvt Ltdarfix

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