Quality Engineer

Role Purpose

The Quality Engineer is 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