Quality Assurance Engineer
4 weeks ago
The Quality Engineer Co-Op will support Quality Engineering activities related to Design Controls, Product & Process Validation, Risk Management, and Lifecycle Management for the Wound Closure and Healing (WCH) or the Biosurgery Platforms. This role will be responsible for learning medical device risk management and performing Application & Design Failure Mode and Effect Analysis for existing and new products.
Duties & Responsibilities
This position will assist in various lifecycle management activities, including product design changes, complaint trending and analysis, assessment of quality signals, CAPA and remediation activities, and integration of regulations, such as the EU MDR, into the business. The Quality Engineer Co-Op will also support the Franchise Technical training program and work to expand it to manufacturing sites.
Qualifications
This hiring is for Fall Co-op 2025. The ideal candidate must be enrolled in an accredited college/university and be actively pursuing a bachelor's or master's degree in engineering, Life Science, Physical Science, or a related field. Completion of the sophomore year of undergraduate school is required. MS digital literacy, including PowerPoint, Word, and Excel, is also necessary. Availability to work 40 hours/week is a must. Demonstrated leadership and/or participation in campus extracurricular and community service activities is preferred. Prior experience in Medical devices or other regulated industries is helpful. Knowledge of statistical analysis and statistical analysis tools such as Minitab is also required.
Required Knowledge, Skills, Abilities, Certifications/Licenses and Affiliations
The Quality Engineer Co-Op is expected to begin the accumulation of the following technical quality areas: Applied statistics, Design control, Good documentation practices, Good manufacturing practices, Organizational requirements, Verbal and written communication skills, Project management, problem solving, presentation skills, and Personal computer skills, Windows: word processing, project planning, presentation, e-mail, and spreadsheet software.
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