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Manufacturing Optimization Expert
18 hours ago
Nordberg Medical is committed to fostering a collaborative environment that encourages innovation and creativity. As a Manufacturing Optimization Expert, you will play a key role in driving the development, optimization, and validation of our manufacturing processes for implantable Class III medical devices.
This role requires around 5-8 years of experience in process engineering within the pharmaceutical or medical device industry, with expertise in at least Class III products. A bachelor's degree in engineering or a related field is required, and a master's degree is preferred.
Key Responsibilities:
- Collaborate with manufacturing teams and alliance partners on production development, technology transfer, and to define and implement efficient, scalable, and compliant production processes.
- Develop, document, and maintain process workflows, control plans, and standard operating procedures (SOPs).
- Lead the design, development, and optimization of manufacturing processes for new and existing implantable medical device (Class III) products.
Process Validation and Qualification:
- Conduct process validation activities, including IQ/OQ/PQ (Installation, Operational, and Performance Qualification) for new and modified manufacturing processes.
- Ensure validation protocols align with regulatory standards (e.g., GMP, ISO 13485, and FDA 21 CFR Part 820) and are executed effectively to meet quality requirements.
- Analyze and document validation results, addressing any deviations or non-conformances.
Continuous Improvement and Optimization:
- Lead root cause analyses for any process failures or deviations, and in collaboration with the Quality Department implement corrective and preventive actions (CAPAs) as necessary.
- Identify, lead, and execute continuous improvement projects to enhance process efficiency, reduce waste, and improve product quality.
Regulatory Compliance and Documentation:
- Ensure all production processes comply with medical device regulations and standards, including FDA, GMP, ISO, and other applicable guidelines.
Benefits:
- A comprehensive compensation package that includes salary, benefits, and bonus structure tailored to your needs.
- Ongoing training and development opportunities to foster your professional growth and ensure you have the resources and support needed for continuous learning and success.
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