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Industrial Process Optimizer
3 weeks ago
We are seeking an experienced professional to oversee and optimize our manufacturing processes for neuro medical devices.
- The ideal candidate will lead the design, implementation, and continuous improvement of manufacturing processes, encompassing product assembly, testing, and packaging.
- This role involves providing hands-on technical support to the manufacturing line, ensuring smooth day-to-day operations and swift resolution of issues.
- The successful applicant will proactively monitor line performance, efficiency, and output, using data-driven insights to drive improvements.
- Maintaining compliance with our Quality Management System (QMS) and applicable policies is essential.
- Identifying and implementing efficiency enhancements to streamline manufacturing workflows and reduce waste is a key aspect of this role.
- The Manufacturing Process Optimization Specialist will support the introduction of new product lines by establishing robust manufacturing processes, tooling, and fixtures.
- Planning, executing, and documenting process validation activities in alignment with regulatory and quality system requirements is also crucial.
- The successful candidate will participate in process risk assessments and contribute to mitigation strategies to ensure robust manufacturing operations.
- Leading and supporting continuous improvement initiatives focused on optimizing product yield, reducing cycle time, and maximizing resource utilization is a vital part of this role.
- Cross-functional collaboration with R&D, Quality Assurance, and Regulatory Affairs is necessary to ensure compliance with industry regulations and internal standards.
- Developing, reviewing, and maintaining detailed process documentation including work instructions, inspection procedures, and batch records is essential.
- Maintaining full traceability of finished goods in accordance with regulatory and internal requirements is also required.
- Managing equipment lifecycle activities, including specification, procurement, installation calibration, and preventive maintenance, is a critical responsibility.
- This role may also involve representing the company during external engagements such as physician line tours, showcasing manufacturing capabilities and quality practices.
- Coordinating with suppliers regarding delivery schedules, quality concerns, and continuous improvement opportunities is another key aspect of this role.
