Quality Assurance Engineer
General Requirements
Quality Engineer develops, establishes and maintains quality-engineering methodologies, systems, and practices which meet customer, and regulatory requirements. Serve as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support assigned departmental, functional, site, company quality goals and priorities. Provide quality engineering support within technical development concepts, new product development, operational, or system/services support. PRIMARY DUTIES AND RESPONSIBILITIES:
• Support development, reviewing and executing test protocols in product development, manufacturing and product field investigation processes.
• Lead the implementation and management of assurances, process controls, and CAPA systems designed to meet internal and external requirements.
• Act as team member in supporting quality disciplines, decisions, and practices in product development, Manufacturing and Procurement.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Advise management on potential improvements or enhancement to quality systems and processes in the company. EXPERIENCE & SKILL REQUIREMENTS:
Quality Engineer should understand the principles of product and service quality evaluation and control. This body of knowledge and applied technologies should include, but are not limited to, development and operation of quality control systems, application and analysis of testing and inspection procedures, the ability to use metrology and statistical methods to diagnose and correct improper quality control practices, an understanding of human factors and motivation, facility with quality cost concepts and techniques, and the knowledge and ability to develop and administer management information systems and to audit quality systems for deficiency identification and correction. EDUCATIONAL REQUIREMENTS:
BS in Engineering/Technical field. MS is preferred.?
3-5 years of? technical experience Working Conditions: General office environment, with occasional domestic and international travel to other facilities, supplier facilities, customer locations and or/meetings and conferences. Competency Expectations:
Familiar with the FDA, ISO,? MDD and the requirements associated with developing products in a regulated industry.
Some understanding of US and? International regulations including 21 CFR, 820, and 11 is required, as well as ISO 13485:2003
Good communication (oral and written) and? presentation skills.
Familiar with Microsoft Office Suite?
Contact Information
Contact: Michael Connolly
Job Location: ,
Email: MConnolly@natleng.com
Phone:800-441-6372
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