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Sterilization Assurance Quality Engineer

Corning · Durham, NC

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Level
Engineer
Team
Quality
Base pay
$67k–$92k
Travel
10%
Degree
Required
Experience asked
3+ years
Industry
Industrial
Posted
30+ days ago

The role in 30 seconds

An engineer-level quality role at Corning (industrial) in Durham, NC.

They ask for
3+ years · degree required
Tools it names
CAPA, ISO 13485, Validation (IQ/OQ/PQ)
Base pay
$67k–$92k
Day to day
about 10% travel

Read from the posting. The full description is below.

From the plant jobs report · week of November 2, 2026

Quality Engineer roles in North Carolina: typical posted base $96k–$143k. This one lists $67k–$92k.

Median of the low and high ends of 21 live postings that list pay, out of 57 quality engineer openings in North Carolina, read from manufacturers' own careers sites.

North Carolina plant jobs report →Pay by team and state →What moves pay →

How this role compares

Against 56 other live quality postings in North Carolina.

Base pay
About 33% below similar roles

Typical $96k–$143k, from 19 postings that list pay.

Experience asked
Less than usual (3+ vs 5+)

Similar roles usually ask 5+ years.

Skills these teams ask for most

  • Root cause 60%
  • ✓ Validation (IQ/OQ/PQ) 42%
  • New product launch 40%
  • Lean 37%
  • FMEA 35%
  • Six Sigma 33%

✓ = this posting asks for it too. % = share of similar postings that mention it.

It asks for 3+ years. If you're close, apply anyway: requirements are a wish list. Talk to someone doing this work there first.

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. 1

    Pick 2–3 people on the Quality team at Corning

    Engineers who joined in the last year or two reply the most. Use the team search on this page to find them.

  2. 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. 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?
    • The posting says about 10% travel. Between which sites?
    • How did you land the job? What stood out in your interviews?
  4. 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. 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: Corning in Durham

3 other open roles at this site.

Full description from CorningAs posted on their careers site.Show

Key Responsibilities

  • ◆Support sterilization and aseptic processing programs for Corning Life Sciences products at the Division and Site level.
  • ◆Help implement changes that improve sterilization compliance, supply flexibility, and process efficiency.
  • ◆Support product transfers to new sterilization methods, sites, or suppliers.
  • ◆Help standardize sterilization

requirements

such as dose ranges, SAL, and validation methods.

  • ✓Provide technical support for sterility claims for terminally sterilized and aseptically processed products.
  • ✓Escalates any issues or concerns appropriately to ensure actions are taken that are commensurate with the risk.
  • ✓Maintain knowledge of applicable standards and regulations, including ISO 11137, ISO 11135, ISO 11737, ISO 13408, ISO 14937, and ISO 13485.
  • ✓Work with Quality, Regulatory, Manufacturing, R&D, Engineering, Supply Chain, and external partners on sterility assurance activities.
  • ✓Support sterilization and aseptic processing validations, requalification’s, and change assessments.
  • ✓Review bioburden, sterility, environmental monitoring, and other microbiological data to support sterility assurance.
  • ✓Support investigations related to sterilization, aseptic processing, contamination control, and sterility issues.
  • ✓Maintain procedures, protocols, reports, and other records related to sterilization and aseptic processing.
  • ✓Support risk assessments, audits, inspections, and training related to sterility assurance.

Experiences/Education - Required

  • ✓Bachelor’s degree in Life Sciences, Chemistry or Engineering or related field of study.
  • ✓1-3 years related experience with sterilization, sterilization assurance, aseptic processing in a manufacturing environment.
  • ✓Working knowledge of sterilization and sterility assurance principles for medical device or life sciences products
  • ✓Familiarity with applicable standards such as ISO 11137, ISO 11135, ISO 11737, ISO 13408, ISO 14937, and ISO 13485
  • ✓Experience supporting sterilization validation, dose audits, requalification, or aseptic processing activities
  • ✓Ability to review and interpret microbiological and environmental data, validation reports, and technical documentation
  • ✓Understanding of quality systems, risk assessment, change control, deviation investigation, and CAPA
  • ✓Strong written and verbal communication skills
  • ✓Good organizational skills and attention to detail
  • ✓Ability to work effectively with cross-functional teams and external suppliers or laboratories
  • ✓Proficiency with standard business software and data analysis tools
  • ✓TRAINING ALIGNED WITH MANUFACTURING & ENGINEERING INSTITUTE LEARNING JOURNEY
  • ✓Track record of delivering results
  • ✓Demonstrated knowledge in a technical field
  • ✓Project team membership

Travel

Requirements

~5-10%

Working Hours: Monday through Friday – minimum of 40 hours/week

Experiences/Education - Desired

  • ✓2+ years’ experience in a regulated manufacturing or life sciences environment
  • ✓Familiarity with statistical methods used in validation, sampling, and trend analysis
  • ✓Experience supporting audits, inspections, and regulatory submissions
  • ✓Ability to assess the impact of product, packaging, or process changes on sterility assurance
  • ✓Strong problem-solving and technical investigation skills
  • ✓ASQ Certifications (CQA / CQE / CMQOE) preferred.
  • ✓Works well with cross-functional teams
  • ✓Communicates clearly with technical and non-technical audiences
  • ✓Uses good judgment to solve technical and compliance issues
  • ✓Manages multiple tasks and deadlines effectively
  • ✓Pays close attention to detail
  • ✓Identifies problems and helps drive solutions
  • ✓Adapts well to changing business and regulatory need
Show full description ↓

Requisition Number: 76297

The company built on breakthroughs. ​

Join us.​

Corning is one of the world’s leading innovators in glass, ceramic, and materials science. From the depths of the ocean to the farthest reaches of space, our technologies push the boundaries of what’s possible. ​

How do we do this? With our people. They break through limitations and expectations – not once in a career, but every day. They help move our company, and the world, forward. ​

​At Corning, there are endless possibilities for making an impact. You can help connect the unconnected, drive the future of automobiles, transform at-home entertainment, and ensure the delivery of lifesaving medicines. And so much more.​

Come break through with us.

Corning’s businesses are ever-evolving to best serve our customers, industries, and consumers. Today, we accelerate and transform life sciences, mobile consumer electronics, optical communications, display, automotive, and solar markets. We are changing the world with:

  • •Trusted products that accelerate drug discovery, development, and delivery to save lives
  • •Damage-resistant cover glass to enhance the devices that keep us connected
  • •Optical fiber, wireless technologies, and connectivity solutions to carry information and ideas at the speed of light
  • •Precision glass for advanced displays to deliver richer experiences
  • •Auto glass and ceramics to drive cleaner, safer, and smarter transportation
  • •Solar polysilicon, wafers, and innovative photovoltaic modules, enabling low-cost solar energy solutions

Role Purpose

The Sterilization Assurance Quality Engineer is accountable and responsible for ensuring the sterility assurance program across CLS complies with specific policies, regulations and standards as they relate to sterilization or aseptic processing. They are responsible for providing support for all sterility assurance activities within CLS manufacturing facilities. Implements policies and procedures at all of CLS locations relating to Quality consistent with the Sterilization Center of Excellence (SCOE), Divisional, and Corporate Quality/Regulatory programs and policies and ensures compliance with regulatory requirements. This position reports to the Sterilization Assurance Program Lead.

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