

New · posted Nov 7
Cook Medical · Medical Devices
Quality Engineering Specialist
- Bloomington, IN
- On-site
- Full-time
- Associate & Specialist
The role
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.
What you need
• 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.
What you'll do
• 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
Where you'll work
Bloomington, INOn-siteOpen in Maps (opens in a new tab)
More jobs in Bloomington, INJob intelligence
The context around this role
Live data · November 7, 2026
Salary intelligence
How the pay compares
Associate & Specialist roles in the US48 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $73,000 | $84,000 | $99,000 |
Comparisons: the base pay employers published on open Quality Engineering roles at the same level on Regulatory Jobs, November 7, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Engineering
The general path across 214 open Quality Engineering roles on Regulatory Jobs, with the titles they carry most. Not Cook Medical's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 8 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Quality systems and risk3
- Data and digital systems3
- Collaboration and leadership3
- Documentation and SOPs2
- GMP and compliance1
- Lab testing and methods1
- Investigations and CAPA1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Engineering work in medical devices, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices, aligned with ISO 13485
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- ISOISO 14971(official source, opens in a new tab)Application of risk management to medical devices
- ISOISO 2859-1(official source, opens in a new tab)Sampling procedures for inspection by attributes (AQL sampling plans)
- IECIEC 62366-1(official source, opens in a new tab)Application of usability engineering to medical devices
- ISOISO 10993-1(official source, opens in a new tab)Biological evaluation of medical devices within a risk management process
- ISOISO 11135(official source, opens in a new tab)Ethylene oxide sterilization of health care products
- ISOISO 11137-1(official source, opens in a new tab)Radiation sterilization of health care products
- ISOISO 11607-1(official source, opens in a new tab)Packaging for terminally sterilized medical devices
- ISOISO 11737-1(official source, opens in a new tab)Determination of the microbial population (bioburden) on medical devices
- FDAFDA Computer Software Assurance(official source, opens in a new tab)Risk-based assurance for production and quality system software
- FDA21 CFR Part 803(official source, opens in a new tab)Medical device reporting of deaths, serious injuries and malfunctions
- FDA21 CFR Part 806(official source, opens in a new tab)Reports of medical device corrections and removals
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilance
- IECIEC 60601-1(official source, opens in a new tab)Basic safety and essential performance of medical electrical equipment
- IECIEC 62304(official source, opens in a new tab)Software life cycle processes for medical device software
Company hiring pulse
Cook Medical on Regulatory Jobs
- 10
- Open roles
- 10
- Distinct roles
- 5
- Locations
By discipline
- Quality7 64%
- Regulatory3 27%
- Clinical1 9%
By level
- Associate & Specialist6 55%
- Senior & Principal5 45%
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Quality Engineering Specialist at Cook Medical
Applications close November 20.


