Quality Engineer - Customer-Facing, CAPA & Regulatory

Socket.dev; Durham (NC); On-site; USD 67,000 - 92,000; Full time

Job summary

Corning is seeking a Quality Engineer responsible for supporting internal and external customers on quality and regulatory inquiries, acting as a liaison with other Corning functions, and supporting CMO-related projects.

Responsibilities include investigations, CAPAs and SCARs, change controls, and ensuring timely documentation for audits while collaborating with Quality, Regulatory, Sales, and Operations. Travel is ~5–10% with a 40-hour work week.

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.
• Demonstrated knowledge of quality and regulatory practices.
• Demonstrated capacity for handling time sensitive varying customer requests.
• Customer facing, manufacturing and/or Quality/Regulatory experience in medical device and/or clinical industries.
• Familiarity with 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.

Responsibilities

• Investigations, corrective actions, and disposal per customer complaints.
• Respond to customers for complaints and inquiries; escalate urgent quality issues.
• Prioritize urgent inquiries to the correct department per QRS guidelines.
• Communicate with contract manufacturers to resolve product concerns.
• Collaborate with Quality, Regulatory, Sales, and Operations to ensure timely deliverables.
• Participate in customer audits and provide documentation within audit scope.
• Issue SCARs, manage CAPAs and nonconformance reports.
• Create change controls to maintain QMS compliance.
• Support sterilization assurance program for CMO products.
• Help implement changes to improve compliance, supply flexibility, and efficiency.
• Escalate issues per risk.

Skills

Quality systems

Regulatory knowledge

Communication skills

Cross-functional teamwork

Data analysis tools

ISO 9001/13485 familiarity

Education

Bachelors in Engineering or Life Sciences

Tools

MS Office

Data analysis tools

Job description

Corning is seeking a Quality Engineer responsible for supporting internal and external customers on quality and regulatory inquiries, acting as a liaison with other Corning functions, and supporting CMO-related projects.

Responsibilities include investigations, CAPAs and SCARs, change controls, and ensuring timely documentation for audits while collaborating with Quality, Regulatory, Sales, and Operations. Travel is ~5–10% with a 40-hour work week.