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Manufacturing Process Specialist
2 months ago
As a key contributor in the field of process engineering, you will play a vital role in enhancing manufacturing practices within the medical devices sector.
Core Responsibilities:
- Collaborate on the validation of equipment through the development of comprehensive protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Lead the development and execution of Test Method Validations to ensure product integrity and compliance.
- Conduct process characterizations and Design of Experiments (DOE) to optimize manufacturing efficiency.
- Update Bill of Materials (BOM) and Device Master Records (DMR) to reflect current processes.
- Provide support in executing protocols and generating detailed reports for analysis.
- Engage in Product Lifecycle Management (PLM) activities, including Change Orders (CO), report routing, and follow-up on approvals.
This role is essential for driving quality and compliance in our manufacturing processes at Dabster.