Quality Engineer, Life Sciences & Regulatory

Corning Inc.

Durham, Northern (NC, KY)

Hybrid

USD 67,000 - 92,000

Full time

41 hours ago

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Benefits offered by this job

Company-wide bonuses

401(k) match

Health, dental, vision

Paid time off

Job summary

Corning Inc. seeks a Quality Engineer to support internal and external customers on quality and regulatory inquiries, act as a liaison with Quality, Regulatory, Sales and Laboratory teams, and help maintain compliance across the CMO projects.

You will investigate issues, drive corrective actions, and ensure timely resolution within the established policies. The ideal candidate has a Bachelor's in Engineering or life sciences, 2–4 years in life sciences or manufacturing, customer-facing

Qualifications

Bachelor's 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.
Knowledge of quality and regulatory practices, ISO 9001 and ISO 13485 encouraged.
Ability to handle time sensitive customer requests and prioritize/escalate.
Customer facing, manufacturing and/or Quality/Regulatory experience in medical device and/or clinical industries.
Familiarity with ISO 9001 and ISO 13485.
Understanding of QMS, risk assessment, change control, deviation investigation, and CAPA.
Good organizational skills and attention to detail.
Clear communication skills, both oral and written.
Ability to work cross-functionally with suppliers or laboratories.
Standard business software and data analysis tools proficiency.

Responsibilities

Performs investigations, implements corrective actions and ensures proper disposition of items related to customer complaints.
Provides responses and manages communications with customers for complaints and inquiries, escalating urgent issues per policies.
Prioritizes key customers and urgent inquiries to the correct department as needed.
Communicates with contract manufacturing organizations to ensure resolution of product concerns.
Collaborates with Quality, Regulatory, Sales, Operations, Scientific Support, and Customer Service to meet customer needs and deliver tasks on time.
Participates in customer audits and provides requested documentation within audit scope.