Quality Engineer

Job Summary

This position will assist in performing the essential duties and responsibilities listed below as required by Tegra Medical ensuring that the customer product requirements and Tegra Medical requirements are met while meeting the requirements of the Tegra Medical ISO 13485:2016 quality management system, regulatory requirements, and environmental, health, and safety requirements.

About the role

• Supports the Quality organization and assist with establishing policies, procedures, and accountability measures that ensure regulatory compliance and continuous quality performance improvement.
• Assisting development, implementation, and continual improvement of the validation/qualification process(es).
• Assisting direction and management of the project development, day-to-day operational aspects of a project and scope.
• Experience with Statistics for validation, design of experiments, and capability analysis.
• Experience with Minitab or equivalent statistical software.
• Superior written and oral communications skills.
• Absorb responsibility for planning, scheduling project timelines and milestones using appropriate tools.
• Absorb responsibility for assisting in the development and delivery of progress reports, proposals, requirements documentation, and presentations.
• Absorb responsibility for assisting in determining the frequency and content of status reports from the project team, analyzing results, and troubleshooting problem areas.
• Absorb responsibility for assisting in the planning and execution of changes in project scope, identifying potential crises, and devising contingency plans.
• Absorb responsibility for assisting in the definition of project success criteria and disseminating them to involved parties throughout the project life cycle.
• Absorb responsibility for assisting in the building, developing, and growing any business relationships vital to the success of the project.
• Absorb responsibility for assisting in customer audits and inspections conducted by regulatory organizations.
• Absorb responsibility for effectively prioritizing and executing tasks in a high-pressure environment.
• Absorb responsibility for reading blueprints, drawings, and printed documents along with inspection criteria supplied by the customer.
• Absorb responsibility for assisting in the determination of measurement methods for new and existing products meeting industry requirements.
• Absorb responsibility for assisting in the planning, setup, and execution of GR&R studies and developing reports.
• Absorb responsibility for assisting in the development and maintenance of quality metrics and communicating trends to all levels of the organization.
• Perform non-routing tasks as assigned by supervision.

Qualifications

• Prior experience in Quality Assurance or Regulatory compliance and in the medical device or related industry is preferred.
• Experience performing validation and qualification of equipment, processes and software in the medical device or related industry.
• Experience with ISO 13485:2016 standard and/or FDA Quality System Regulations and Environment, Health, & Safety regulations is a plus.
• Bachelor’s degree preferably in a technical field and a minimum of 4 years work experience, or equivalent combination of education and experience.

Physical Requirements

• Frequent performing repetitive work.
• Occasional lifting (max. 40 lbs.).
• Occasional carrying (max. 40 lbs.).
• Subject to physical hazards from moving equipment and machine parts.
• Constant safety glasses.
• Constant full PPE.
• Frequent standing.
• Occasional sitting, walking, pushing, pulling, reaching.