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Production Engineering Specialist
2 months ago
Job Title: Manufacturing Engineer
Key Responsibilities:
- Design and implement corrective action plans to resolve compliance challenges associated with manufacturing processes.
- Work collaboratively with interdisciplinary teams to formulate comprehensive action strategies and timelines for resolution.
- Ensure prompt and effective execution of corrective measures to adhere to regulatory standards.
- Lead initiatives to establish process controls that guarantee manufacturing quality and uniformity.
- Set up monitoring frameworks to oversee process metrics and identify discrepancies.
- Facilitate training sessions for personnel on newly established or revised process controls.
- Regularly evaluate the efficiency of process controls and initiate enhancements as necessary.
- Revise documentation for all manufacturing processes within Product Lifecycle Management (PLM) systems, ensuring precision and compliance.
- Maintain accurate records of modifications, updates, and versions of manufacturing documentation.
- Assist in projects aimed at improving labeling systems by contributing to the design and execution of upgraded labeling solutions.
- Collaborate with IT and quality assurance teams to enhance labeling software and data management systems.
- Formulate and implement procedures for labeling that ensure precision and adherence to regulatory standards.
Skills and Qualifications:
- Thorough understanding of manufacturing methodologies, particularly concerning packaging.
- Experience in designing and refining production layouts for manufacturing processes.
- Demonstrated experience in developing and validating manufacturing processes for efficiency and compliance.
- Knowledge of Corrective and Preventive Action (CAPA) processes for addressing and mitigating quality concerns.
- Ability to perform comprehensive root cause analysis and execute corrective measures.
- Expertise in identifying underlying causes of process challenges and formulating effective solutions.
- Experience with Gemba walks to observe and enhance manufacturing processes.
- Dedication to continuous improvement through Lean, Six Sigma, or other quality enhancement methodologies.
- Six Sigma certification (Green Belt or Black Belt) is preferred.
- In-depth knowledge of packaging and labeling regulations specific to medical devices.
- Familiarity with regulatory standards such as FDA and ISO pertaining to medical device packaging.
- Understanding of global packaging regulations, including ISO, FDA, and other pertinent standards.
- Experience in ensuring manufacturing processes and documentation comply with regulatory requirements.
Educational Requirements:
- Bachelor's degree in Packaging Engineering, Mechanical Engineering, Manufacturing Engineering, or a related discipline.
- Advanced degrees or certifications in relevant fields are advantageous.
Experience Requirements:
- Years of experience in manufacturing engineering, preferably within the medical device sector.
- Experience with PLM systems and quality management systems is highly desirable.
