Quality Engineer

Quality Engineer

Date: Feb 5, 2025

Location: Manassas, VA, US, 20109

Company: Corning

Requisition Number: 66770

Corning is vital to progress ? in the industries we help shape and in the world we share.

We invent life-changing technologies using materials science. Our scientific and manufacturing expertise, boundless curiosity, and commitment to purposeful invention place us at the center of the way the world interacts, works, learns, and lives.

Our sustained investment in research, development, and invention means we're always ready to solve the toughest challenges alongside our customers.

As a leading developer, manufacturer, and global supplier of scientific laboratory products for 100 years, Corning?s Life Sciences segment collaborates with researchers seeking new approaches to increase efficiencies, reduce costs and compress timelines in the drug discovery process. Using unique expertise in the fields of materials science, surface science, optics, biochemistry and biology, the segment provides innovative solutions that improve productivity and enable breakthrough discoveries.

Role Purpose

Develops, modifies, applies and maintains quality evaluation systems and procedures for processing materials into finished product.

Collaborates with engineering and manufacturing functions to ensure quality standards are in place.

Devises and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.

Areas of specialization include design, validation, root cause analysis, statistical risk management, production control or product evaluation and reliability as they apply to product or process quality.

May be certified in lean and six-sigma quality engineering methodologies.

May also be responsible for PEx project portfolio assuring the effective use of different improvement methodologies (DMAIC, Lean, DESGN, etc.) toward the achievement of plant strategic goals.

Exercises judgment within defined procedures and practices to determine appropriate action.

Key Responsibilities

Lead and participate in project teams to quickly and effectively implement improvement initiatives or manufacturing process improvements.

Provide manufacturing support activities to include validation projects, equipment validation projects, and or involvement in improvement projects related to products or services consistent with FDA requirements for medical device products.

Participate in continuous improvement and Performance Excellence activities to include leading, participating, or coaching project teams, facilitating events, or providing training.

Provide technical support and guidance to other Mediatech staff and/or project team members in Quality Systems improvement efforts.

Apply quality engineering practices and guidance to support project teams and manufacturing operations using Six Sigma tools, FMEA, CE Diagram, CE Matrix, DOE, MSA, Validation Protocol development, review, approval and Control Plans.

May lead execution of validation protocols.

Develop/Revise Quality Plans including incoming, in-process and final inspection, and provide training to those affected by the plans.

Perform technical reviews and interprets data for accuracy of equipment/process performance.

Write Technical Reports and Protocols, as needed, and write, revise, and review SOPs.

Frequently interacts with colleagues, team members, supervisors, and other teams/departments.

Oversees the change management program to assure there is a proper technical review of requested changes and that there is a risk assessment of requested changes.

Manages CAPAs assigned to the QE department to closure and assures corrective actions are effective.

Participates in MRB, reviews and/or completes nonconformance reports, FIRs, and CAPA documents to assure root cause analysis is reached and corrections are appropriate to prevent further nonconformances.

Reviews QS metrics and makes recommendations for corrective actions.

Serves a resource for performing internal audits to ensure quality system compliance.

Some travel is required as part of the job responsibilities.

Requirements

Bachelor's Degree ? Engineering, Quality, Life Sciences or related field.

Minimum of 3 years of experience in a Manufacturing environment or within a Quality function

Validation experince is stronly preferred

Knowledge/experience in a regulated industry (cGMP, GLP, ISO, etc.)

Proficiency with Microsoft Office products (Word, PowerPoint, Excel, Visio).

Experienced with investigations using tools like (5Y, 8D, etc.)

Demonstrated technical writing skills.

Working knowledge of databases and spreadsheet applications to perform necessary tasks for preparing required data analysis, reports, documents and general communication.

Able to use a systematic approach to drive to root cause understanding of problems to assure validity of corrective actions

Desired Skills

Advanced degree ? Life Sciences or related field.

Prefer exposure to ISO13485 and 21CFR820.

Experience preforming CAPA, SCARS and risk assessments.

Advanced proficiency with Microsoft Office products (especially in Visio and Excel).

Familiarity/experience with Six-sigma/Lean.

Understanding of typical (bio)pharmaceutical industry manufacturing strategies/processes/equipment.

Proficiency with Minitab software.

ASQ certifications preferred.

Exposure to aseptic processing concepts.

Uses rigorous processes and data to solve problems

Can apply academic and experiential technical knowledge to solve problems

This position does not support immigration sponsorship.

The range for this position is $79,108.00 - $108,774.00

assuming full time status. Starting pay for the successful applicant is dependent on a variety of job-related factors, including but not limited to geographic location, market demands, experience, training, and education. The benefits available for this position are dependent on hours worked and may include medical, dental, vision, 401(k) plan, pension plan, life insurance coverage, disability benefits, and PTO.

Corning Puts YOU First!

We are committed to supporting your health, financial, career development, and life goals as you grow professionally and personally to achieve your highest potential. All benefits begin as soon as you start your career at Corning.

Our monetary peer-to-peer recognition program is tied to ourand celebrates you and your colleagues? contributions.

Health and well-being benefits include medical, dental, vision, paid parental leave, mental health/substance use, fitness, and disease management programs.

Financial benefits include a 401(k) savings plan with company matching contributions and a 100% company-paid pension benefit that grows steadily throughout your career.

Companywide bonus and attractive short- and long-term compensation programs are available based on your role and responsibilities.

Professional development programs help you grow and achieve your career goals.

We prohibit discrimination on the basis of race, color, gender, age, religion, national origin, sexual orientation, gender identity or expression, disability, veteran status or any other legally protected status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To request an accommodation, please contact us at.

Nearest Major Market: Washington DC