Manufacturing Specialist
1 month ago
This role involves providing essential tools and support to engineering and production teams while ensuring alignment with company quality and cost standards. Responsibilities include developing and implementing processes, procedures, equipment, fixtures, and training programs, all adhering to sound engineering principles and compliance with Good Manufacturing Processes (GMP) and ISO standards.
Key Responsibilities:- Drive Continuous Improvement initiatives by identifying, executing, and promoting objectives to enhance quality and reduce costs for projects.
- Support Lean Manufacturing initiatives by assisting in defining requirements and processes to enhance quality and reduce costs for projects.
- Develop comprehensive and understandable technical documentation, including written technical descriptions of processes and procedures.
- Participate in Material Review Board deliberations concerning material dispositions and provide engineering support as needed.
- Collaborate with cross-functional teams as assigned to achieve project goals and objectives.
- Maintain compliance with procedures and regulations, including maintaining regulatory requirements and adhering to safety protocols.
- Experience in engineering/manufacturing for medical devices.
- Knowledge of FDA regulations and cGMP principles (ISO 9001, ISO 13485).
- Preferred experience with Silicone molding.
- Proficiency in Pro-E / CREO and/or SolidWorks desirable.
- Proficiency in Microsoft software.
- Ability to interpret technical drawings and specifications.
- Excellent communication and organizational skills.
$25-33/hr
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Manufacturing Specialist
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Manufacturing Process Specialist
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Medical Device Production Specialist
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Medical Device Production Specialist
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CNC Machinist Specialist
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Quality Assurance Specialist
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