Specialist, Quality Engineering
Ellettsville, INFull-timeSeen 2 days agoSeen in employer's feed today
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Job overview
The Quality Engineering Specialist supports, reviews, and analyzes quality system processes and works with an interdisciplinary team to advance Quality Engineering’s strategic goals. The role drives improvement initiatives, investigates quality issues, monitors quality processes, and participates in assessments and audits. It also leads quality projects and supports compliance with applicable regulatory requirements, including FDA 21 CFR 820 and ISO 13485.
Skills & qualifications
Skills
Qualifications
Full job description
Overview
The Quality Engineering Specialist supports, reviews, and analyzes 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
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Drives project improvement initiatives with minimal oversight.- Monitor and report project progress, delays, and completions while involving management at the appropriate times- Investigate quality issues.- Communicate with other departments to identify and troubleshoot project issues.- Provide feedback to management on areas for improvement from a systems and personnel standpoint.- Monitor and maintenance of processes critical to CMLLC Quality Management system.- Participate in internal and external quality assessments/audits.- Must be able to multi-task.- Independently produce and organize and maintain document or systems critical to the foundation of the department.- Lead short term, long term, or system forward projects.- Organize and participate in quality projects.- Understanding of regulatory requirements.- Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.- Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.
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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 communication skills and ability to work in a collaborative and independent work situations and environments with minimal supervision.- Ability to remain calm and receptive in fast paced situations.
Qualifications
- 1-2-years of Quality Assurance or relevant experience.- Knowledge of medical device regulations, including pertinent standards.- Computer literacy and proficiency.- Experience in statistical and analytical reasoning preferred.- CQA or like certification preferred.- Bachelor's degree in a technical field or equivalent experience preferred.- Knowledge of Cook quality systems, associated documentation and product lines preferred.
Requisition ID2026-19730
Posting Date2 days ago(11/9/2026 1:10 PM)
Job Location(s)Ellettsville IN United States
Job LocationsUS-IN-Ellettsville
TravelLess than 10%
Position TypeFull Time
CompanyCook Inc - Ellettsville
CategoryQuality
How this job compares
Set against the 1,100 open Quality Engineering jobs on Olive Jobs, counted November 12, 2026.
- Pay
- This postingNot listed
- US median$116–183K/yr655 salary ranges
- US median$25–35/hr95 hourly ranges
- Openings
- Olive Jobs lists 22 open Quality Engineering jobs in Indiana and 1,100 across the US. 7% of them nationwide are listed as remote or flexible.
- Hiring the most in Indiana
- Cleveland-Cliffs Inc.3 open
- BAE Systems2 open
- Cognizant2 open
- Experience
- This posting asks for at least 1 year of experience — less than three in four Quality Engineering postings that state a minimum ask for (median 6 years, across 808 postings).
- Education
- 417 of the 1,100 open Quality Engineering jobs (38%) ask for a bachelor's degree or higher.
Counted across the open, public US postings on Olive Jobs on November 12, 2026. Pay medians are the middle values of the low ends and of the high ends of postings that list both ends of a range in the same cadence (a yearly salary or an hourly rate); a range's midpoint is halfway between its ends. Pay and experience figures resting on fewer than 20 postings are left out.
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