- Lead quality engineering initiatives with a focus on project management, ensuring projects are completed on schedule and within budget.
- Collaborate with cross-functional teams to coordinate tasks and streamline processes for optimal efficiency.
- Utilize expertise in manufacturing process output measurements to drive continuous improvement initiatives.
- Implement process monitoring strategies, including critical quality feature analysis, severity modes assessment, and Failure Mode and Effects Analysis (FMEA).
- Demonstrate proficiency in technical writing, producing accurate and detailed documentation to support quality assurance efforts.
- Utilize Six Sigma methodologies to drive process improvement initiatives.
- Possess experience in product line decommissioning and validate engineering processes as needed.
- Manage quality improvement initiatives for assigned clients, ensuring compliance with regulatory requirements.
- Utilize project planning and scheduling skills to effectively manage project timelines and resources.
- Bachelor's degree in Engineering, Technical Field, or equivalent (advanced degree preferred)
- Minimum of 5 years of experience in quality engineering.
- Previous experience in project management, leading at least two projects.
- Strong knowledge of manufacturing process monitoring and implementation.
- Proficiency in technical writing and documentation.
- Experience with Six Sigma methodologies and FMEA.
- Previous experience with product line decommissioning is preferred.
- Familiarity with validation engineering processes.
- Medical device experience is preferred but not required.
- Proficiency in MS Office suite is required.
- Familiarity with Infinity Quality System (IQS) is highly preferred.
- Experience with CAPA (Corrective and Preventive Actions) is advantageous.
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