Quality Engineering Specialist

Regulatory Jobs; Bloomington (IN); Presencial; USD 65.000 - 90.000; Jornada completa

Descripción de la vacante

Cook Inc. in Bloomington, IN is seeking a Quality Engineering Specialist to support and review quality system processes within an interdisciplinary engineering team. You will investigate quality issues, monitor essential QMS processes, and perform data trending and reporting to advance the department's strategic goals.

Excellent communication and collaboration across global teams are essential for success. This role requires attention to safety, ability to work independently with minimal

Formación

• AS or BS degree in a relevant field.
• 2 years experience related to essential job functions.
• Independent work experience with minimal supervision.
• Proficient in Microsoft Office.
• Knowledge of Cook Inc. quality systems and medical device regulations.
• Strong oral and written communication.
• Ability to interact across a global organization.
• Must adhere to safety requirements.
• Regular and punctual attendance.
• Legally authorized to work in the United States; no visa sponsorship.

Responsabilidades

• Investigate quality issues.
• Monitor and maintain processes critical to the QMS.
• Internal and external quality assessments.
• Data trending and reporting.
• Must multi-task and manage multiple tasks.
• Independently organize and maintain documents and systems.
• Lead short- and long-term system improvements.

Conocimientos

Oral and written communication

Analytical skills

Problem solving

Team collaboration

Attention to safety

Educación

AS or BS degree in relevant field

Herramientas

Microsoft Office

Descripción del empleo

Overview

The Quality Engineering Specialist supports and reviews quality system processes and works with an interdisciplinary team of engineers and specialties along with their department to advance the strategic goals of Quality Engineering.

Responsibilities

• Investigate quality issues
• Monitor and maintenance of processes critical to CMI Quality management system
• Internal and external quality assessments
• Data trending and reporting
• Must be able to multi-task
• Independently produce and organize and maintain document or systems critical to the foundation of the department
• Lead short tearm, long term, or system forward

Qualifications

• AS or BS degree in relevant field; or
• 2 years experience that relates directly to the above essential job functions/duties
• Experience working independently and with minimal supervision
• Working knowledge of Microsoft Office Software (ie Word, Excel)
• Knowledge of Cook Inc. quality systems, associated documentation and product lines
• Knowledge of medical device regulations, including pertinent standards
• Must have effective oral and written communication skills
• Must work and interact effectively and professionally with and for others throughout various levels of the global organization
• Must strictly adhere to safety requirements
• Maintain regular and punctual attendance
• Must maintain company quality and quantity standards
• Must have effective oral, written and presentation communication skills
• Ability to work in collaborative and independent work situations and environments with minimal supervision
• Ability to remain calm and receptive in fast paced situations
• Must have excellent analytical and problem solving skills
• Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

Physical Requirements

• General office environment
• Sitting for extended periods
• Requires close visual acuity when working with computers, etc.