Manufacturing Process Specialist
1 day ago
Collaborate with cross-functional teams and external suppliers to develop and implement new manufacturing processes. This involves optimizing existing processes to improve productivity, quality, and efficiency.
Analyze process data to identify areas for improvement, conduct risk assessments, and implement corrective and preventive actions. Lead process validation activities, including IQ, OQ, and PQ protocols.
Develop and document manufacturing procedures, work instructions, and quality standards to ensure regulatory compliance. Provide technical support and troubleshooting expertise to resolve manufacturing issues.
Design transfer from R&D to manufacturing is a key responsibility, ensuring seamless integration of new products into production.
Evaluate and select materials, components, and equipment with suppliers to ensure quality and cost-effectiveness. Implement and manage process controls, including statistical process control (SPC), test method validation, and process validation activities.
Bachelor's or Master's degree in Engineering or a related field is required, along with solid experience in medical device manufacturing, operations, and engineering. Strong knowledge of manufacturing processes, including assembly, testing, and packaging is essential.
Key skills include quality management systems, regulatory requirements for medical devices, process validation, risk management, and statistical analysis techniques. Excellent problem-solving skills and the ability to analyze complex manufacturing issues are also crucial.
A strong communicator with excellent interpersonal skills is needed to collaborate effectively with cross-functional teams.
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