Quality Management System Specialist

Requisition Number: 67315

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

Reporting directly to the Compliance Supervisor, this position will perform change controls, create and update quality management procedures, manage site records, and perform training in compliance with the ISO 13485 Quality Management System. Assists with the analysis of data for quality management system metrics and supports quality management system projects.

Responsibilities

• Generate, reviews, and maintains Device Master Records, Certification of Conformances, and other Quality System Documents in compliance with ISO 13485, ISO 15378, and 21 CFR 820 standards.
• Initiates Change Controls and Document Change Requests. Provides training to plant employees on the change management and documentation change processes. Acts as an EtQ quality management system software administrator.
• Improves Quality databases and spreadsheets in order to continuously improve compliance metrics.
• Assists the Quality Compliance Supervisor with other quality system tools i.e. deviations, internal audits, CAPA, NCPR’s etc.
• Assists the Quality Compliance Supervisor to manages quality system metrics reporting and maintaining metrics reports for the plant and communicates with division.
• Assist to manage the distribution of controlled documents.
• Provide label verification for master product and bulk labels. Assists to manage supplier acknowledgement process for quality system documents distributed to suppliers.
• Assists to manage plant document review and retention processes.
• Assists to manage database for customer inquiries.
• Supports or leads continuous improvement initiatives for quality management related processes. May also support continuous improvement initiatives in other areas.
• Works within department and with various departments to fulfill approved document distribution requests.
  
  

Requirements

• Bachelor’s Degree
• 2 plus years of work equivalent experience (work in a manufacturing environment is preferred).
• Root cause analysis and data-driven problem solving.
• Consistent track record on improving processes and working on teams to influence others.
• ISO 13485 Quality Management Systems knowledge.
• Ability to interface with all levels inside and outside of the organization.
• Proficient with Microsoft Office Applications.
  
  

Desired Experience/ Skills

• Previous experience ETQ preferred.
• Auditor background
• Must be detail oriented and accurate.
• Ability to apply basic mathematical concepts such as percentages, ratios, and proportions to practical situations.
• Experience leading safety programs in manufacturing environment.
• Experience with environmental and other regulatory permitting for federal, state and local agencies.
  
  

This position does not support immigration sponsorship.

The range for this position is $66,478.00 - $91,407.00 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 our Values and 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 accommodations@corning.com .