The Quality Control Technician is responsible for Quality Control activities, including the inspection of incoming and in-process materials, as well as final inspection of medical products, deviations, nonconforming material reports, corrective and preventive action, and non-conformance investigation. May participate in internal/external audits as needed.
3 Month Temp to Perm
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Familiar with cGMP and ISO standards for medical devices. Specifically, FDA 820 CFRs/ISO 13485 quality management system requirements
- Familiar USP requirements related to product testing representative samples that releases outgoing products to customers.
- Performs incoming, in-process, and final inspection activities
- Conducts Quality Systems tracking and trending for assigned areas
- May conduct product release activities per company procedures
- Familiar utilizing AQL rules, sample plans, and digital calipers for conducting raw material inspections and releases.
- Performs task-related recordkeeping activities required to meet company and regulatory standards
- Reviews product test-records and associated certificate of analysis for accuracy and completeness
- Execute sampling plans by applying procedurally driven sampling methods
- Prepares reports by analyzing and summarizing data, and making recommendations
- Supports process validation activities as needed
- Supports regulatory inspections; may act as scribe for hosting inspections
- Conducts activities with a focus on compliance, effectiveness, and efficiency
- May assist with/conduct internal audits and associated corrections
- Completes required training in applicable procedures before conducting work in those areas
- Maintains professional and technical knowledge by attending workshops, seminars, reviewing professional publications, participating in professional societies, and maintaining professional certifications.
- 2 Plus years Quality Control experience in GMP or ISO environment
- Strong written and verbal communication skills
- Attention to detail
- High School Diploma or GED
For more information please send and updated Word Version of your resume to Aaron Tibbetts at email@example.com