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 quality policy and quality objectives established for the Tegra Medical ISO 13485:2016 quality management system, regulatory requirements, and environmental, health, and safety requirements.

The role of the Quality Engineer is to assist in the planning, executing, and finalizing projects according to strict deadlines and within budget. Specific functional areas include, but are not limited to, preparation and execution of protocols for performance qualifications and product characterizations for new product introductions, perform design transfer activities related to the product, processes, and measurement tools/methods (Gauge R&R). The Quality Engineer will also assist defining the project’s objectives and oversees quality assurance throughout its life cycle.

Role and Responsibilities

• 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.

• Assist planning and scheduling project timelines and milestones using appropriate tools.

• Assist development and delivering progress reports, proposals, requirements documentation, and presentations.

• Assist determining the frequency and content of status reports from the project team, analyze results, and troubleshoot problem areas.

• Assist to proactively manage changes in project scope, identify potential crises, and devise contingency plans.

• Assist to define project success criteria and disseminate them to involved parties throughout project life cycle.

• Assist building, developing, and growing any business relationships vital to the success of the project.

• Assists in customer audits and inspections conducted by regulatory organizations.

• Ability to effectively prioritize and execute tasks in a high-pressure environment .

• Ability to read blueprints, drawings, and printed documents along with inspection criteria supplied by the customer.

• Assist with determining measurement methods for new and existing products meeting industry requirements.

• Ability to plan, setup, and execute GR&R studies and develop reports.

• Ability to develop process flow diagrams, PFMEA’s, and inspection criteria for use in manufacturing.

• Assist with developing and maintaining 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.

Education Requirements

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.

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