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SUMMARY/RESPONSIBILITIES:
This position is responsible for the throughput of incoming inspection and product testing while ensuring applicable product/component quality control specifications are met. Assist the company in maintaining compliance to regulations, procedures, and work instructions.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned on an individual basis:
Quality Control
- Preparing inspection plans and coordinating the completion of inspections to meet production demand.
- Conducting inspection and testing following controlled procedures and test methodology.
- Performing final product acceptance testing.
- Record and analyze the inspection and testing data to determine if acceptance criteria has been met.
- Review completed production lot history records to ensure completeness and good documentation requirement have been met.
- Perform production line audits to ensure process steps are being followed by the production staff.
Initiate/Address Quality Control Issues
- Initiate nonconformances when inspection criteria failed to meet specifications.
- Ability to describe and detail observed defects.
- Assist in the disposition activities for nonconforming material.
- Participate in investigations and root cause analyses for identified issues and recommend improvements.
Equipment Control
- Coordinates the calibration and preventative maintenance schedule for equipment in the quality control laboratory.
- Assist in the qualification and installation of inspection/testing equipment
Continuous Improvement
- Proactively supports continuous improvement and lean manufacturing processes
- Makes/implements recommendations for quality system improvements
Document Control & Filing
- Responsible for the completion of and storage of inspection records.
- Assists with maintaining electronic and hard copy logs used for assigning document numbers, tracking current document revisions, tracking document changes and releases, tracking externally referenced documents and standards, and tracking the locations of controlled documents
Training
- Assists in training team members or peers on test methods and inspection methodology.
- Maintains personal training compliance in accordance with company policy.
Complaint Handling
- May assist in complaint investigations with a focus on returned device evaluation and production record review.
Other
- Actively promote and support the Quality Management System, Quality Objectives, and Quality Policy.
- Assure that you and functional subordinates (if applicable) are trained on all applicable procedures and processes according to Good Manufacturing Practices, applicable FDA and Regulatory requirements.
- Actively promote and support the company’s Management Review process.
- Inform responsible personnel of concerns involving product quality.
- Perform job functions in a safe and effective manner
EDUCATION/EXPERIENCE:
- High school education and a minimum of 5 years quality control work experience in the medical device industry.
- Experience working with catheters, endovascular or neurological devices (preferred)
- Working knowledge about quality system requirements (FDA 21 CFR Part 820 and/or ISO 13485), as they relate to quality control processes and good manufacturing practices
- Strong communications skills (both written and verbal)
- Must be able to perform multiple tasks concurrently with accuracy
- Proficiency with Microsoft Office products