Lucas Group has partnered with a medical device manufacturer in the North metro Atlanta area seeking to hire a Quality Auditor. He/she will be responsible for ensuring daily production activities adhere to specified bill of materials, work instructions, and quality standards for each product line. Plans, executes and prepares clear and concise written reports of audit or review observations, including an assessment of compliance during internal audits of facility quality systems.
- Supports Quality management, which includes ensuring that corrective and preventive actions are issued as required, properly investigated, documented, effective, and completed on time, and that audits are properly performed, documented, and completed in accordance with the annual audit procedure/schedule.
- Facilitates and consults with corrective action teams in implementing changes to ensure compliance with all applicable QSR/ISO/MDD/CMDR and other applicable requirements.
- Performs re-audits and/or effectiveness verification as a way of assessing and documenting CAPA Effectiveness
- Issues to management timely written audit reports and follows up on audit activities to ensure appropriate corrective action.
- Escalates audit findings to the appropriate level of management.
- Bachelor’s degree in Engineering or Scientific field or equivalent is required.
- ISO 13485 Lead Auditor is required.
- ASQ-CQA (Certified Quality Auditor) is preferred.
- Ability to prioritize and multi-task successfully in a fast-paced environment
- Ability to work both independently and in a collaborative team setting.
- Ensures Manufacturing compliance to cGMP & cGDP requirements and alerts supervisors when issues are identifies
- Promotes improvement through problem solving techniques, 5S and other lean manufacturing processes.