Quality Engineer

Corning; Durham (AR); On-site; USD 67,000 - 92,000; Full time

Benefits offered by this job

Bonuses & incentives

401(k) matching

Health benefits

Paid time off

EAP

Life insurance

Disability insurance

Parental leave

Job summary

Corning is seeking a Quality Engineer to provide support for internal and external customers on quality and regulatory inquiries, and to act as a liaison with other Corning functions. The role covers projects and processes tied to the CMO, including investigations, CAPAs, and change controls.

You will collaborate with Quality, Regulatory, Sales, and Operations to ensure timely delivery of project deliverables, participate in customer audits, and help strengthen the QMS and process efficiency

Qualifications

• Bachelors in Engineering, life sciences, or related field.
• 2-4 years related experience in life sciences or manufacturing industry.
• Customer facing interactions to address concerns and resolve issues.
• Demonstrated knowledge of quality and regulatory practices strongly encourage.
• Understanding of quality systems, risk assessment, change control, deviation investigation, and CAPA.

Responsibilities

• Performs investigations, implements corrective actions and ensures proper disposition of items as they relate to customer complaints.
• Provides responses and manages communications with customers for complaints and inquiries, identifying and escalating urgent quality and regulatory issues as needed according to the established policies and guidelines.
• Prioritizes key customers and urgent inquiries to the correct department as needed on demand according to QRS guidelines
• Communicates with contract manufacturing organizations to ensure resolution of any product concern.
• Work with customers and internal departments (Quality, Regulatory, Sales, Business Operations, Scientific Support, Customer Service) to ensure customer satisfaction and completion of any project deliverable in a timely manner.
• Participate in customer audits, working with customers and Plant Quality management to provide requested documentation within audit scope. Assure that all necessary components and agreements are in place prior to customer audit.
• Issues supplier corrective actions (SCARs), manages CAPAs and Nonconformance reports to ensure proper resolution of issues, implementation of corrective actions and effectiveness of such corrective actions.
• Creates change controls related to projects and changes necessary to maintain and support compliance of the QMS.
• Supports the sterilization assurance program for CMO products as deemed necessary.
• Help implement changes that improve compliance to the quality management system (QMS), supply flexibility, and process efficiency.
• Escalates any issues or concerns appropriately to ensure actions are taken that are commensurate with the risk.

Skills

Customer interactions

Communication skills

Cross-functional teamwork

Time management

Regulatory knowledge

Quality systems

Attention to detail

Quality standards

Medical device experience

Data analysis tools

Education

Bachelors in Engineering, life sciences, or related field

Tools

MS Office

Data analysis tools

Job description

Requisition Number: 78327

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.

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

The Quality Engineeris accountable and responsible for providing support for internal and external customers regarding quality and regulatory related inquiries and issues and act as quality liaison with other Corning functions. Responsible for supporting the projects and ongoing processes associated with the CMO.

Key Responsibilities

• Performs investigations, implements corrective actions and ensures proper disposition of items as they relate to customer complaints.
• Provides responses and manages communications with customers for complaints and inquiries, identifying and escalating urgent quality and regulatory issues as needed according to the established policies and guidelines.
• Prioritizes key customers and urgent inquiries to the correct department as needed on demand according to QRS guidelines
• Communicates with contract manufacturing organizations to ensure resolution of any product concern.
• Work with customers and internal departments (Quality, Regulatory, Sales, Business Operations, Scientific Support, Customer Service) to ensure customer satisfaction and completion of any project deliverable in a timely manner.
• Participate in customer audits, working with customers and Plant Quality management to provide requested documentation within audit scope. Assure that all necessary components and agreements are in place prior to customer audit.
• Issues supplier corrective actions (SCARs), manages CAPAs and Nonconformance reports to ensure proper resolution of issues, implementation of corrective actions and effectiveness of such corrective actions.
• Creates change controls related to projects and changes necessary to maintain and support compliance of the QMS.
• Supports the sterilization assurance program for CMO products as deemed necessary.
• Help implement changes that improve compliance to the quality management system (QMS), supply flexibility, and process efficiency.
• Escalates any issues or concerns appropriately to ensure actions are taken that are commensurate with the risk.

Travel Requirements

~5-10% (minimal)
Working Hours: Monday through Friday – minimum of 40 hours/week

Experiences/Education - Required

• Bachelors in Engineering, life sciences, or related field
• 2-4 years related experience in life sciences or manufacturing industry.
• Customer facing interactions to address concerns and resolve issues.
• Demonstrated knowledge of quality and regulatory practices strongly encourage
• Demonstrated capacity for handling time sensitive varying customer requests and prioritizing/escalating tasks accordingly.
• Customer facing, manufacturing and/or Quality/Regulatory experience in medical device and/or clinical industries
• Familiarity with applicable standards such as ISO 9001 and/or ISO 13485.
• Understanding of quality systems, risk assessment, change control, deviation investigation, and CAPA.
• Good organizational skills and attention to detail.
• Courteous, articulate and professional oral and written communication skills.
• Ability to work effectively with cross-functional teams and external suppliers or laboratories.
• Proficiency with standard business software, and data analysis tools to design and maintain reports/metrics.

Experiences/Education - Desired

• Knowledge of glass, plastics, and laboratory equipment manufacturing preferred but not required.
• Experience working with contract manufacturers preferred but not required
• Ability to work under pressure while maintaining professional and positive composure.
• Ability to quickly adapt to changing priorities
• Ability to apply good judgment and business acumen.
• Desire to anticipate, meet and exceed the expectations and needs of our customers, internal and external.
• Positive attitude and outlook to drive a culture of collaboration and teamwork.
• Ability to handle proprietary and delicate situations appropriately, positively and professionally
• Capability to effectively and professionally communicate with customers and colleagues from various regions and industries
• Maintains clear documentation and follows through on actions
• Focuses on customer needs, product quality, and compliance

This position does not support immigration sponsorship.

The range for this position is $67,237.00 - $92,451.00 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.

A job that shapes a life.

Corning offers you the total package.

Your well-being is our priority. Our compensation and benefits package supports your health and wellness, financial aspirations, and career from day one.

• Company-wide bonuses and long-term incentives align with key business results and ensure you are rewarded when the company performs well. When Corning wins, we all win.
• As part of our commitment to your financial well-being, we provide a 100% company-paid pension benefit with fixed contributions that grow throughout your career. Combined with matching contributions to your 401(k) savings plan, Corning’s total contributions to your retirement accounts can reach between 7% and 12% of your pay, depending on your age and years of service.
• Our health and well-being benefits include medical, dental, vision, paid parental leave, family building support, fitness, company-paid life insurance, disability, disease management programs, paid time off, and an Employee Assistance Program (EAP) to support you and your family.
• Getting paid for our work is important, but feeling appreciated and recognized for those contributions motivates us much more. That’s why Corning offers a recognition program to celebrate successes and reward colleagues who make exceptional contributions.

Your well-being is our priority. Our compensation and benefits package supports your health and wellness, financial aspirations, and career from day one.

• Company-wide bonuses and long-term incentives align with key business results and ensure you are rewarded when the company performs well. When Corning wins, we all win.
• As part of our commitment to your financial well-being, Corning provides company matching contributions to your 401(k) savings plan of up to 4% of pay when you contribute at least 6% of pay.
• Our health and well-being benefits include medical, dental, vision, paid parental leave, family building support, fitness, company-paid life insurance, disability, disease management programs, paid time off, and an Employee Assistance Program (EAP) to support you and your family.

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.

Corning is committed to providing equal employment opportunities and considers requests for reasonable accommodations in accordance with applicable laws. Individuals with disabilities or sincerely held religious beliefs may request reasonable accommodations to participate in the application or interview process, perform essential job functions, or access other benefits and privileges of employment. To submit a request for reasonable accommodation related to disability or religion, please contact us at [e-mail].