A-Line Staffing is now hiring
Product Complaint & Requirements Analyst in
Covington, GA 30014. The Product Complaint & Requirements Analyst would be working for a Major Medical Device Manufacturer and has career growth potential.
Product Complaint & Requirements Analyst Highlights:
- Schedule: Monday – Friday, 8:45 AM – 5:45 PM
- Pay Range: $33/hour
Product Complaint & Requirements Analyst Responsibilities:
- Provides support to Project Teams and Quality Department
- Responsible for all product testing in the Complaint Laboratory
- Provides Quality Engineering technical support to assist in resolving quality issues, including complaint review and investigation
- Performs complaint investigations for all UCC products and applicable OEM manufactured products
- Creates and manages investigation files in the complaint system (Trackwise)
- Coordinates complaint investigation files and collaborates with manufacturing sites to ensure timely completion
- Sets up, safely operates, and maintains laboratory equipment and testing instruments
- Performs tests and experiments in accordance with GMP and GLP requirements
- Maintains working knowledge of company policies, ISO standards, and FDA requirements
- Maintains accurate data, performs analysis, and assists in drawing conclusions
- Ensures high attention to detail and accuracy in all tasks
- Works in a biohazard environment while complying with all safety procedures
- Ensures compliance with departmental and divisional procedures
- Interfaces with manufacturing facilities, suppliers, and Product Legal Manufacturer (PLM) groups
- Presents findings to peers, engineering teams, and management as needed
- Provides timely notifications to FA specialists based on new information to meet FDA reporting requirements
Product Complaint & Requirements Analyst Qualifications:
- Basic knowledge of medical device regulations and industry standards
- Strong laboratory skills and familiarity with bench methods and equipment
- Understanding of laboratory instrumentation
- Knowledge of OSHA, QSR, GLP, ISO, AAMI, and FDA guidelines
- Broad understanding of manufacturing processes
- Knowledge of fundamental engineering principles
- Associate degree in a science-related field
- Prior laboratory experience preferred
- ASQ certification (CQE, CQA, CQM, etc.) is a plus
- Proficiency in MS Excel (pivot tables, VLOOKUP, etc.)
- 2–3 years of experience in a regulated industry (internships/co-ops acceptable)
If you are interested in this
Product Complaint & Requirements Analyst position, please apply to this posting with Luke H. at A-Line!