Manufacturing Process Optimization Specialist
7 days ago
Our organization is seeking a skilled Manufacturing Process Optimization Specialist to join our team. This role will be responsible for supporting the development and implementation of manufacturing processes that meet quality, efficiency, and regulatory requirements.
Key Responsibilities:
- Assist in evaluating manufacturing processes by conducting audits and validation activities.
- Validate new products, product changes, and enhancements, as well as related tooling and fixtures.
- Improve manufacturing efficiency by analyzing and planning workflow, space requirements, and equipment layout.
- Process qualifications and validations, including equipment qualifications and material specifications.
- Ensure product and process quality by designing testing methods and establishing standards.
- Provide decision-making information by calculating production, labor, and material costs.
- Prepare reports by collecting, analyzing, and summarizing information and trends.
- Responsible for Health & Safety within assigned areas.
Requirements:
- Bachelor's degree in Engineering or similar technical field with 2 to 5 years' experience in high-volume production environment.
- Strong interpersonal skills with ability to communicate effectively at all levels.
- Proficient in DOE and statistical techniques.
- Certified LEAN/6Sigma preferred.
- Knowledgeable in defining process capabilities and control charting.
- Writing of protocols for validations and qualifications.
- Knowledge of FDA, GMPs, ISO 9001, and Medical Device Directives.
This is an exciting opportunity to work in a fast-paced environment with a dynamic team. If you are motivated and have a passion for optimizing manufacturing processes, we encourage you to apply.
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