Job Position: Quality Engineer
Location: Waynesville, NC 28786
Pay Rate: $90000.00-105000.00
QUALITY ENGINEER
POSITION SUMMARY:
The Quality Engineer assists in planning, development, implementation, communication and maintenance of the quality management systems, policies, documentation, data and customer-specific requirements for all Sulfate Manufacturing facilities
ESSENTIAL DUTIES AND RESPONSIBILITIES
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Monitor, assess and improve inspection processes for raw materials and finished goods along with corresponding work instructions and documentation
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Responsible for daily, weekly and monthly inspection reports
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Key User of Master Control QMS Software
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Monitor, analyze and trend quality performance
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Ensures that workflows, processes, and products comply with all regulatory and safety requirements
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Corrective/Preventive Action owner to drive actions, solutions and improvements
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Primary driver of the Change Control process including all necessary inputs and outputs
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Support Equipment Validation activities per regulatory compliance
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Ability to perform risk assessments for new equipment, processes, or changes to either
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Work in conjunction with the Quality Team to support and perform internal audit-readiness activities as well as support the Team for Regulatory and Customer audits
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Ability to communicate effectively with all levels of staff and management, both internal and external
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Excellent organization skills with the ability to perform multiple tasks and obtain results working within strict time frames
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Strong attention to detail
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Solid knowledge of good manufacturing practices within an FDA-regulated facility
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All other duties, responsibilities, and activities that may be assigned.
EDUCATION and/or EXPERIENCE:
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Bachelor’s degree in engineering or equivalent discipline or work experience
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Minimum of 2 to 5 years’ experience in a manufacturing environment preferred
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Experience with FDA: CFR 210/211 preferred
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ISO 9001-2018 experience preferred
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Root cause analysis, analytical and problem-solving experience preferred
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ASQ Certification preferred
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Intermediate to advanced math and statistical skills
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Ability to communicate technical terms in common sense manner to all levels of organization and externally
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Strong organizational and information management skills required
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Proficient in Microsoft Office products
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Solid base of knowledge with respect to Quality Management Software
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Ability to work in cross-functional teams
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Excellent project management skills
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Capacity to work independently from general supervision (must be self-motivated once given guidance/direction)
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Good oral and written communication