Quality Engineer

Employment Type

: Full-Time


: Engineering

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 and by regulatory 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 not limited to, preparation and execution of Quality Engineering deliverables for specific customer requirements, maintaining multiple project plans staying within project timelines and for assisting with continuous improvements efforts. The Quality Engineer will also assist defining the project’s objectives and oversees quality control/assurance throughout its life cycle.

Essential duties and responsibilities:

Supports the Quality organization and assists with establishing policies, procedures, and accountability measures that ensure regulatory compliance and continuous quality performance improvement

Assist with the development, implementation, and continual improvement efforts of the validation/qualification process(es) including equipment, measurement and test instrumentation, special processes and re-qualifications

Lead Quality Engineering efforts with direction and management of project development, day-to-day operational aspects of a project and scope

Assist with Design for Manufacturing Quality Engineering efforts

Quality Engineering liaise with project stakeholders on an ongoing basis

Experience with Statistics for validation and design of experiments

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 with development and delivering progress reports, proposals, requirements documentation, and presentations

Assist with determining the frequency and content of status reports from the project team, analyze results, and

troubleshoot problem areas

Assist in proactively managing changes in project scope, identifying potential crises, and devising contingency plans

Assist with defining 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

Supports the Quality organization and establishes policies, procedures and accountability measures that ensure regulatory compliance and continuous quality performance improvement

Assists in customer audits and inspections conducted by regulatory organizations

Ability to effectively prioritize and execute tasks in a high-pressure environment is crucial

Secondary Responsibilities (Non-Essential Functions):

Ability to read blue prints, drawings, and printed documents

Database and operating systems experience with Quality Mgmt., SPC, others

Experience at working both independently and in a team-oriented, collaborative environment is essential

Can conform to shifting priorities, demands and timelines through analytical and problem-solving capabilities

Reacts to project adjustments and alterations promptly and efficiently

Flexible during times of change

Ability to elicit cooperation from a wide variety of sources, including upper management, clients, and other departments

Ability to bring project to successful completion through political sensitivity

Strong interpersonal skills

Must be able to learn, understand, and apply new technologies

Ability to apply common sense understanding to carry out instructions furnished in written, oral or diagram form

Ability to work independently with minimal supervision

Ability to use Microsoft computer software, word processing, spreadsheets, e-mail, Internet and other software required to perform essential duties and responsibilities

Qualification Requirements:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education and/or Experience:

degree preferably in a technical field and a minimum of 4 years work experience, or equivalent combination of education and experience. 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 certified Quality Engineer is a plus.

Environmental Environment:

The work environment characteristics describe here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The noise level in the work environment is usually moderate to noisy. Hearing protection is not required for normal duties but may be required for some special situations.

Tegra Medical is an Equal Opportunity Employer

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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