Quality Engineer, Complaint Management
The Quality Engineer, Complaint Management is responsible for providing quality control on customer complaints in compliance with New World Medical’s requirements and all necessary regulations. This position oversees, but is not limited to, complaint handling, equipment, calibration and pest control. Other duties may include interactions with surgical sales consultants, customer service, production and clinical advisory from education & training. The Quality Engineer, Complaint Management is expected to participate and initiate continuous improvements for the Quality Control department and will report to the Quality Control Manager.
ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:
Perform all work in compliance with company policy and within the guidelines of New World Medical’s Quality System.
- Responsible for investigation, resolution, and reporting of all customer related complaints.
- Perform visual inspection of returned products, review Device History Records for compliance, maintain RGA/CFB Logs, complete sample investigation, and closure of customer evaluation reports in accordance to the existing regulations and guidelines.
- Obtain necessary information/updates from other departments for the resolution of the complaint.
- Take lead in preparing, compiling and coordinating reports/data analysis for presentation to upper Management in the form of executive summaries.
- Equipment & Calibration Management – Planning, Maintaining, Organizing, Monitoring and Scheduling. Their duties include purchasing, maintenance, repair, inventory, transportation, storage, cleaning, and liquidation.
- Pest Control – Ensure that the program is maintained and all records are filed.
- Inputting data into quality database (SPC) to maintain SPC charts and analyze results.
- Initiate Non-Conformity Reports (NCRs), and follows up for completion of disposition.
- Reports quality issues or findings to QC Manager and follows up to ensure corrective actions are executed in a timely manner.
- Lead improvements activities for quality and supports continuous improvement through Kaizen.
- Undertake and complete assignments as determined by QC Manager or from the department head.
KNOWLEDGE, SKILLS AND ABILITIES:
- Must be able to adapt to change in the workplace and demonstrate flexibility with new ideas.
- Ability to communicate in writing and orally with supervisors and co-workers.
- Good understanding of operational environment and analytical skills.
- Must be self-motivated and a good team player.
- Proficiency in using Microsoft Office Applications (MS Word, MS Excel, MS PP, MS Outlook).
- Experience in Complaint Handling; familiarity with Quality System Regulations and ISO 13485.
- Experience with SAP, MiniTab, and SOP writing is a plus.
EDUCATION AND EXPERIENCE:
- 3+ years of professional experience in complaint handling, preferably in a medical device industry.
- Bachelor’s degree in engineering or equivalent science field, required.
- Additional professional certifications, a plus.
New World Medical, Inc. (NWM) is an Equal Opportunity Employer. NWM takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.