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
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.
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.
Launch your career - Create your profile now!Create your Profile
Loading some great jobs for you...