
Manufacturing Process Lead
4 days ago
Nordberg Medical AB is seeking a skilled Manufacturing Process Lead to drive the development, optimization, and validation of manufacturing processes for our medical devices. This role involves scaling up projects, improving efficiency and product quality, and collaborating with cross-functional teams to implement advanced manufacturing techniques.
This position requires strong analytical thinking, attention to detail, effective communication skills, and collaboration abilities.
Key Responsibilities- Lead the design, development, and optimization of manufacturing processes for new and existing medical device products.
- Collaborate with manufacturing teams and alliance partners on production development, technology transfer, and efficient, scalable, and compliant production processes.
- Develop, document, and maintain process workflows, control plans, and standard operating procedures (SOPs).
- Conduct process validation activities, including Installation, Operational, and Performance Qualification (IQ/OQ/PQ) for new and modified manufacturing processes.
- Evaluate and ensure validation protocols align with regulatory standards (e.g., ISO 13485, GMP, 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.
- Identify, lead, and execute continuous improvement projects to enhance process efficiency, reduce waste, and improve product quality.
- 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.
- Evaluate and ensure all production processes comply with medical device regulations and standards, including FDA, ISO, and other applicable guidelines.
- Prepare, review, and maintain comprehensive documentation related to process design, validation, and improvement activities.
- Around 5-8 years of experience in manufacturing engineering or process engineering, preferably within the medical device, pharmaceutical, or regulated healthcare industry.
- Bachelor's degree in engineering (e.g., Mechanical, Biomedical, Industrial, or Manufacturing Engineering) or related field. A master's degree is a plus.
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