Quality Manufacturing Engineer

Smiths GroupIrving, TX
20h

About The Position

As the Senior Quality Assurance Engineer, you will be responsible for establishing and maintaining quality activities that ensure our quality requirements are met and continuously improved. You will identify critical processes and ensure compliance through analysis, reviews, audits, demonstrations, inspections, testing, and metrics to maintain system capability and control. Key responsibilities include: Manage the completion of internal, external, and third-party audits (ISO 9001, AS 9100, ISO 14001, OHSAS 18001, and others) in accordance with established schedules and requirements. Establish and maintain effective root cause analysis and closed-loop corrective action processes across various databases, ensuring timely resolution and implementation of corrective measures. Develop and present critical-to-quality (CTQ) data and quality metrics to senior management and cross-functional stakeholders to support informed decision-making. Ensure customer requirements are understood and compliance is maintained through root cause analysis, corrective action planning, and implementation oversight. Lead the deployment and effective utilization of quality tools and methodologies (8D, 5 Why, FMEA, Control Plans, and 7 QC Tools) across departments to drive continuous improvement initiatives. Oversee the Change Management Review Process to ensure all requirements are fully identified, documented, and validated. Maintain and enhance Environmental, Health, and Safety Management Systems and Quality Management System documentation and controls to ensure ongoing capability and compliance. Contribute to departmental functions including meetings, goal setting, training development, and process improvement activities. Review High Reliability orders with attention to detail, ensuring Certificate of Conformance (C of C) and data summary requirements are met and documented. Execute additional assignments and special projects as directed by the department supervisor.

Requirements

  • Bachelor of Science degree in Engineering, or equivalent of 5-10 years of professional quality assurance experience. A combination of both education and experience is preferred.
  • Demonstrated experience working in laboratory environments and manufacturing settings.
  • Comprehensive knowledge of quality management principles and practices.
  • Proficiency in reading and interpreting safety regulations, operating instructions, and technical procedure manuals.
  • Strong written and verbal communication skills with the ability to prepare detailed technical reports and correspondence.
  • Advanced data analysis capabilities with demonstrated expertise in statistical quality control tools including Statistical Process Control (SPC), Process Capability Index (CPK), and Design of Experiments (DOE).
  • Competency in the use of precision measurement instruments including calipers, micrometers, and optical comparators.
  • Ability to efficiently extract and interpret product information from work orders, test manuals, and engineering specifications.
  • Thorough understanding of ANSI/NCSL Z540-1 calibration system requirements and standards.
  • US Citizenship or permanent resident status required.

Nice To Haves

  • Professional certifications such as Certified Quality Engineer (CQE) or Certified Auditor of Quality (CAQ) are preferred.

Responsibilities

  • Manage the completion of internal, external, and third-party audits (ISO 9001, AS 9100, ISO 14001, OHSAS 18001, and others) in accordance with established schedules and requirements.
  • Establish and maintain effective root cause analysis and closed-loop corrective action processes across various databases, ensuring timely resolution and implementation of corrective measures.
  • Develop and present critical-to-quality (CTQ) data and quality metrics to senior management and cross-functional stakeholders to support informed decision-making.
  • Ensure customer requirements are understood and compliance is maintained through root cause analysis, corrective action planning, and implementation oversight.
  • Lead the deployment and effective utilization of quality tools and methodologies (8D, 5 Why, FMEA, Control Plans, and 7 QC Tools) across departments to drive continuous improvement initiatives.
  • Oversee the Change Management Review Process to ensure all requirements are fully identified, documented, and validated.
  • Maintain and enhance Environmental, Health, and Safety Management Systems and Quality Management System documentation and controls to ensure ongoing capability and compliance.
  • Contribute to departmental functions including meetings, goal setting, training development, and process improvement activities.
  • Review High Reliability orders with attention to detail, ensuring Certificate of Conformance (C of C) and data summary requirements are met and documented.
  • Execute additional assignments and special projects as directed by the department supervisor.
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