Custom manufacturing and precision machining company seeks a Quality Engineer to work directly with management and manufacturing personnel to establish and implement manufacturing plans and risk assessments. This position will manage compliance activities with a focus on continual improvement. The Quality Engineer will analyze process and performance data to drive corrective action and continuous improvement.
- Process improvement, Lean, 5S, SS.
- Work with Tulip (Training Provided).
- Comfortable leading a group.
- Understand statistical analysis – IQ OQ PQ – used in medical devices and FDA approvals.
- Product acceptance activities – use checklists for visuals inspections prior to chipping (last set of eyes).
- Review customer’s contracts, the scope of work, specifications, blueprint drawings, and other information to understand manufacturing, quality, and regulatory requirements.
- Facilitate the development of manufacturing plans and risk assessments in accordance with the identified requirements.
- Create and maintain process documentation including work instructions, checklists, and other required documentation according to project needs
- Create and maintain test procedures and plans prior to manufacturing.
- Conduct product acceptance activities as a quality representative for the final shipment of the product.
- Lead root cause and corrective action efforts using applicable problem-solving tools to resolve product and process nonconformities.
- Analyze and trend quality data to drive corrective action and continuous improvement.
- Facilitate improvement projects to improve internal processes and customer project performance.
Bachelor’s degree in quality, mechanical, or industrial engineering or related discipline.
5- 10 years of experience in quality engineering, quality assurance, or a similar role.
Required Skills & Qualifications:
- Demonstrated ability to work in a team environment
- Excellent verbal and written communication skills
- Experience in ISO 9001
- Experience in various root cause analysis methods and applying corrective actions
- Experience in applying Lean Manufacturing techniques
- Knowledge of Excel and Pivot Tables
- Experience with DMG Mori TULIP app development (a plus, not mandatory)