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Process Improvement Specialist
2 months ago
We are seeking a highly skilled Quality Engineering Specialist to join our team at J. Sterling Industries. As a key member of our quality management team, you will be responsible for ensuring the highest standards of quality in our manufacturing processes and products.
Key Responsibilities- Process Development and Implementation: Develop and implement quality-related processes and documentation for new program development and current sustainment business.
- Manufacturing Process Improvement: Direct involvement in manufacturing process development and continuous improvement to meet or exceed the company's quality metrics and process metrics for current and new business.
- Quality Issue Resolution: Review, analysis, and resolution of customer/internal/supplier quality issues through root cause analysis and implementation of corrective actions.
- Preventative Actions and Continuous Improvement: Development and implementation of preventative actions and continuous improvements within the manufacturing and quality areas.
- Non-Conformance Management: Control of the non-conformance area (inventory, disposition, and associated costs).
- Gage Management: Purchase, management, and review of gage equipment, certifications, and calibrations, including programming CMM or other coordinate measurement equipment.
- Quality Metrics and Reporting: Ensure the Gage calibration log is complete and up to date, and coordinate with the quality inspector for the daily inspection, measurement, test, and approval of all components, product, process, and use of quality metrics to ensure quality targets are met.
- Communication and Collaboration: Communicate and coordinate with management, administrative, operations, quality, and engineering departments.
- Quality Management System Software: Daily use of quality management system software and SPC systems.
- Auditing and Compliance: Participate in conducting supplier and internal system and process audits.
- Education: Engineering bachelor's degree, with background in quality statistics, metrology, biomedical technologies preferred.
- Experience: 3-5 years' experience in a quality department in a medical device OEM or contract manufacturer ISO registered environment.
- Certifications: ISO 13485:2016 Auditor Training Certificate preferred.
- Skills: High volume workload requires a conscientious attitude with accuracy and attention to detail, knowledge and experience on ISO 9001:2015 (ISO 13485:2016 preferred), process capability, problem-solving methods (5Y, Fishbone, 8D, etc.), and ability to be self-managed and directed from a satellite operation.
