QA Engineer

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.

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, and automotive markets.

Purpose

Supervision of documentation and in-process quality functions in compliance with Good Manufacturing Practices and ISO 9001 & ISO 13485 to ensure that we maintain and manage the Document Control Process at all stages, working in conjunction with departments to ensure an effective document control system.

Responsibilities

• Assure that all activities performed are in compliance with ISO, GMP’s, FDA, Corporate and Unit SOPs.
• Identify Quality System deficiencies and implement changes that continually improve the system.
• Compile, summarize, and submit relevant information on identified quality data sources for Management Review.
• Ensure communication of audit deficiencies, receipt of corrective/preventive actions, and timely closure of actions and effectiveness checks.
• Requires use of statistical data analysis, excellent at objective analysis and interpretation.
• Maintain updates to the Quality Manual and Quality Assurance Procedures.
• Lead Management Reviews.
• Support ISO, FDA, and customer audits.
• Responsible as Supervisor of Document Control and CAPA's.

Skills & Knowledge

• BS Degree or minimum of 3 years manufacturing experience.
• Must demonstrate initiative in keeping the activities of the complaint, CAPA system, and audit system up to date with experience in medical devices.
• Minimum of two (2) years practical experience in Quality Assurance role for GMP regulations, 21 CFR Part 820, and ISO 13485.
• Minimum of two (2) years practical experience in Quality Systems related areas, such as CAPA, Customer Complaints, Internal and External Audits, preferably in medical devices.
• Internal auditor on ISO9001, ISO13485.
• Must be proficient in PC software (Word, Excel, PowerPoint, Minitab, Visio, Access), with a minimum of two (2) years of experience in word processing, spreadsheet applications, and databases to perform tasks associated with trending, creation of templates for tracking, revision, and modification of documentation.
• Advanced English proficiency.

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, mental health/substance, fitness, and disease management programs.

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.