SUMMARY
The QA Technician will have the responsibility to inspect raw incoming materials, as well as manufactured products (QC Inspection and Lot Release testing). This new opportunity is ideal for someone desiring a fast paced, cutting edge working environment. You will work onsite in a small team to bring new products and processes into reality.
PRINCIPAL DUTIES AND RESPONSIBILITIES
- Conduct necessary incoming, in process, and final quality inspections using proper equipment and techniques
- Conduct statistical analysis on select processes and report findings
- Assist with problem solving - root cause analysis - corrective actions
- Maintain accurate documentation of quality inspection results
- Ensure incoming materials are in compliance to required specifications
- Perform Final Product Release, ensuring outgoing products are in compliance with required specifications and Device History Record (DHR) DHR is complete
- Ensure that equipment are current for calibration and preventive maintenance (PM)
- Assist in development and maintenance of Quality procedures and work instructions
- Collaborate with Materials and Production resources to ensure that inventory needs are met
- Administrate and escalate issues with Non-Conforming Material
- Support the Engineering team with projects, as needed.
EXPERIENCE REQUIREMENTS
- At least 6 years relevant experience in the medical device industry
- Experience in an ISO 13485 / Medical Device production environment
- Experience with various measuring devices such as calipers, micrometers, etc.
EDUCATION REQUIREMENTS
OTHER QUALIFICATIONS
- Ability to adheres to established specifications, procedures, and policies in inspections
- Excellent computer skills, including ability to work effectively with Microsoft Excel and Word
- Understanding of Quality System, Good Manufacturing Practices and Good Documentation Practices