Quality Engineer 2, Manufacturing
Cook Medical · Bloomington, IN
- Level
- Engineer
- Team
- Quality
- Degree
- Required
- Experience asked
- 5+ years
- Industry
- Medical devices
- Posted
- 30+ days ago
The role in 30 seconds
An engineer-level quality role at Cook Medical (medical devices) in Bloomington, IN. Perform work per external and internal quality standards• Interface with internal and external groups on quality-related issues• Support product development and transfer to manufacturing• Facilitate development and implementation of production controls (e.g.
- They ask for
- 5+ years · degree required
- Tools it names
- Six Sigma, Root cause, CAPA, ISO 13485, FDA / GMP, Validation (IQ/OQ/PQ)
Read from the posting. The full description is below.
From the plant jobs report · week of November 2, 2026
Quality Engineer roles in Indiana: typical posted base $97k–$145k.
Median of the low and high ends of 15 live postings that list pay, out of 53 quality engineer openings in Indiana, read from manufacturers' own careers sites.
Indiana plant jobs report →Pay by team and state →What moves pay →
How this role compares
Against 52 other live quality postings in Indiana.
- Base pay
- Not listed in this posting
- Experience asked
- Typical (5+ years)
Typical $97k–$145k, from 14 postings that list pay.
Similar roles usually ask 5+ years.
Skills these teams ask for most
- ✓ Root cause 68%
- SPC 45%
- FMEA 43%
- Control plans 38%
- Supplier quality 36%
- ✓ Validation (IQ/OQ/PQ) 36%
✓ = this posting asks for it too. % = share of similar postings that mention it.
Stands out: this posting asks for ISO 13485, which few similar roles mention. If you have it, lead with it.
At a glance
Pulled from the posting text. If it's not listed here, the posting didn't say.
How to get in at this plant
Five moves over a week or two. The first one takes ten minutes.
- 1
Pick 2–3 people on the Quality team at Cook Medical
Engineers who joined in the last year or two reply the most. Use the team search on this page to find them.
- 2
Send a short, curious note
One real question about their work. No favors yet. Each person gets a different note, written for this role.
- 3
Turn a reply into a short call
Questions worth asking about this team:
- What does a normal week look like on your team?
- Which standards drive the work here: ISO 13485, IATF 16949, AS9100?
- How much of the job is customer complaints versus prevention?
- How did you land the job? What stood out in your interviews?
- 4
Apply with someone vouching for you
If the call went well, ask whether they’d pass your résumé to the hiring manager. Send your résumé link, apply that day, and let them know.
- 5
Bring proof to the interview
One page of before-and-after numbers from projects you led: scrap, OEE, cycle time, cost. Plant managers hire on results.
This plant: Cook Medical in Bloomington
9 other open roles at this site.
- Manufacturing Engineering Specialist, Documentation · Manufacturing
- Manufacturing Engineer 1 · Manufacturing
- Manufacturing Engineering Specialist · Manufacturing
- Supplier Quality Engineer 2 · Quality
- Manufacturing Engineer 2 - NPI · Manufacturing
- Sr. Manufacturing Engineer - Value Engineering · Manufacturing · Senior
Full description from Cook MedicalAs posted on their careers site.ShowHide
Responsibilities
- ◆Perform work per external and internal quality standards• Interface with internal and external groups on quality-related issues• Support product development and transfer to manufacturing• Facilitate development and implementation of production controls (e.g. qualification, process capability, sampling plans, validation, etc.)• Perform investigation of product nonconformance/complaints, root cause analysis, monitoring/trending of process and product, and escalation of identified issues• Plan, review, and approve change requests• Execute risk assessment as needed and facilitate development and completion of risk file documentation• Conduct Risk-based decision making and effective resolution of issues• Lead or support CAPAs as necessary
- ◆May interface with internal or 3rd party audits (e.g. FDA, Notified Body, etc.)• Drive continuous improvement efforts through facilitating, leading, and collaborating with cross function teams including quality, engineering, production, clinical, and regulatory affairs.• Provide leadership in the understanding of medical device regulations and best practices• Manage conflict resolution as it relates to technical situations• Must work and interact effectively and professionally with and for others throughout various levels of the organization• Must strictly adhere to safety
Qualifications
- ✓Bachelors degree in engineering
- ✓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. • Demonstrates knowledge of medical device regulation (ISO 13485, 21CFR) and risk management (ISO 14971)
- ✓3-5 years of experience• Professional certification (e.g. ASQ, Six Sigma, etc.) preferred• Proficiency in statistical, quality and continuous improvement methods and tools
- ✓Proficiency in the Microsoft Office suite of products (Word, Excel, PowerPoint, and Outlook) is required.• Strong organizational skills• Critical thinking and attention to detail required• Excellent verbal communication skills and technical writing
Physical
Requirements
- ✓Works under general office environmental conditions, including time in manufacturing environment and biohazard lab• Sitting for extended periods, utilizes close visual acuity for working with computers, equipment, etc.• Occasional travel may be required
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Overview
The Quality Engineer at Cook Inc. serves as the lead quality representative of certain product lines within product development, manufacturing, post-market surveillance, and/or CAPA.