Quality Systems Specialist, Medical Devices & Data

Regulatory Jobs; Bloomington (IN); On-site; USD 65,000 - 90,000; Full time

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Skills

Oral and written communication

Analytical skills

Problem solving

Team collaboration

Attention to safety

Education

AS or BS degree in relevant field

Tools

Microsoft Office

Job description

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