MINIMUM REQUIREMENTS: The Quality Engineer position requires experience and skill in driving standardization, consistency and improvement of quality systems and GMP’s across all shifts in their functional area of responsibility, including special projects. This position is a key leader who provides direction, support, leads projects, drives consistency, and leads problem solving for areas associated with plastics injection molding equipment related to medical device quality systems. Candidate is responsible to lead the quality assurance & medical device standardization efforts within our TX Plant as designated.
DUTIES AND RESPONSIBILITIES:
This position will be responsible for the quality process including critical process characteristics, standards, audits, complaint resolutions, training and laboratory functions related to FDA 21 CFR 820 and ISO 13485:2016.
- Integration of quality systems to ensure a common quality system throughout the facility and share best practices across the North American plant locations
- Provide manufacturing personnel with quality systems and tools to allow effective evaluation of products and processes
- Ensure the application of advanced quality tools to provide process improvement to the manufacturing group.
- Ensure the quality management system meets the company’s medical device expectations and goals
- Formulate and maintain accurate documentation to meet all quality system and medical device expectations
- Provide leadership and direction to the quality team.
- This position will report directly to the Quality Manager.
- This is a high visibility role with the opportunity to work closely with manufacturing, customer service and other quality professionals to problem solve and support new and existing projects.
- Lead and manage direct and indirect reports within the facility to meet or exceed targets for the medical device quality management system
- Maintain all aspects of the ISO 8 cleanroom including system validation and ongoing environmental monitoring Proactively review and improve quality systems and processes
- Investigate moderately complex manufacturing product quality and compliance issues (e.g. CAPA, non-conformances, audit observations) in design and production processes prior to final product customer release. Make recommendations and confirm results
- Assist in the development and initiate standards and methods for inspection, testing, and evaluation, utilizing quality engineering analytical tools. Formulate quality assurance policies and procedures.
EDUCATIONAL AND OTHER SKILL REQUIREMENTS:
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- Bachelor’s degree required; preferable in an appropriate technical discipline (Engineering, Math, & Science).
- At least two years related experience; medical device experience highly preferred.
- At least two years’ experience with plastic molding equipment and rotating machinery highly preferred.
- Must have a working knowledge of statistics, SPC and design of experiments.
- Must have the ability to lead production employees and engineers in the use of advanced statistical methods.
- Must have experience in ISO methodology, procedures and quality system implementation.
- Must have familiarity with GMPs used in the food and food packaging industries; experience in medical device environments highly preferred.
- Must have familiarity with FDA regulations as they apply to food packaging and food safety; experience in medical device regulations highly preferred.
- Must have good computer skills and be knowledgeable in the use of Excel, Word, and statistical software such as Minitab. Additionally, background experience in CAD would be desired.
- Must have experience in dealing with customers and customer complaints
- Must be familiar with physical inspection processes, tools, equipment and gauging as well as conducting gauge reproducibility and repeatability studies.
- Teamwork, positive communication with others, and team problem solving are required.