Specialist, Quality Complaint Investigation

Baxter

  • Marsa, Malta Island
  • Permanent
  • Full-time
  • 21 days ago
This is where you save and sustain livesAt 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.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.
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’s degree in Engineering and 1-3 years of Medical Device experience
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.Reasonable 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 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 .

Baxter