Complaint EngineerAnnons: 28252992
Yrke: Kvalitetsingenjör/-tekniker, maskin
Arbetsgivare: BAXTER Luleå
Arbetets ort: Luleå, Norrbottens län
Senaste ansökningsdatum: 2023-12-16
KvalifikationerSpråk: Engelska; Svenska
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. 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.
The Quality Complaint Engineer has primary responsibility for investigation, review, and completion of all Quality Engineering Complaint issue analysis tasks utilizing various quality system inputs
Essential Duties and Responsibilities:
- Review individual complaints and associated service data to determine risk level and complete investigation into the “as “determined” problem code and cause codes.
- Serve as a primary point of contact for quality related matters within the assigned duties.
- Conduct or lead cross-functional complaint meetings to drive and follow up on complaint investigations and complaint reduction projects
- 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, risks and systemic issues. Prepare and issue reports based on information analysis.
- Ensure appropriate key performance indexes are defined, implemented and reported out in a timely manner for processes and procedures.
- 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.
- Assists in other quality and regulatory areas if required.
- Medical Device Experience with knowledge of EU MDR and 21CFR820 preferred
- Investigational research skills
- Experience with any statistical software packages
- 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 reading and understanding blueprints and technical drawings.
- Demonstrated strong analytical problem solving and Root Cause Investigations
- Display a solid technical understanding of engineering principles and procedures.
- Computer competency in Word, Excel, Power Point and PowerBi.
- Excellent communication skills both written and verbal
- Fluent in Swedish and English, other languages are beneficial
Education and/or Experience:
- A Bachelor’s degree in Engineering/equivalent international degree
- 1-3 years of Medical Device experience is a plus
- Quality/Regulatory experience required