Quality Engineering Manager — Medical Devices

RiseMe; Plainsboro Township (NJ); On-site; USD 109,000 - 150,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

Life insurance

Savings plan (401(k))

Disability insurance

Job summary

Integra LifeSciences is seeking a Quality Engineering Manager to lead QA/QC, validation, risk management, and technical investigations in a medical-device manufacturing environment. You will partner across Manufacturing, Regulatory, Product Development, and QA to ensure compliant, robust processes and product transfers.

The role emphasizes building a strong quality engineering team, defining verification plans, and guiding CAPAs.

Qualifications

• BS degree in Engineering or Science.
• ASQ/CQE certification preferred.
• Excellent written and verbal communication.
• Working knowledge of GMP, Quality Engineering, validation, risk management, and applicable Quality System requirements; medical-device industry experience strongly preferred.

Responsibilities

• Lead Quality Engineering support for Manufacturing, QA/QC, Regulatory Compliance, Product Development, and other business partners.
• Build and develop a strong team of quality engineers through effective hiring, onboarding, coaching, goal setting, retention, and resource planning.
• Participate in the development and implementation of new processes, process and product transfers, continuous improvement activities, and technical issue resolution.
• Provide guidance on verification and validation plans, process validation and revalidation, test methods, sampling methods and plans, test equipment acquisition, sterilization validation and revalidation, and Process Excellence initiatives.
• Lead or support technical investigations involving product, process, equipment, test method, validation, and manufacturing performance issues.
• Provide Quality Engineering partnership and technical expertise for nonconformances, CAPAs, and customer complaint investigations, including technical assessment, investigation support, risk evaluation, root-cause analysis, action development, and effectiveness evaluations, as applicable.
• Ensure Quality Engineering deliverables and assigned technical investigation activities are complete, accurate, scientifically sound, appropriately documented, and completed within established timelines.
• Lead and document product and process risk-management activities within the Quality Engineering scope, including risk assessments supporting investigations, process changes, validation, transfers, and issue resolution.
• Analyze engineering and manufacturing data, including process capability, statistical process control, validation results, recurring technical issues, and other relevant quality indicators, to identify opportunities for improvement and risk reduction.
• Participate in the compilation and review of technical documentation supporting domestic and international regulatory submissions, inspections, and audits.
• Participate in external and internal audits, including FDA, Notified Body, customer, and corporate audits, by providing Quality Engineering subject-matter expertise and objective evidence.
• Benchmark regulatory and industry practices and participate in professional forums or committees that influence engineering, validation, risk-management, and quality practices.

Skills

Communication

Education

BS in Engineering or Science

ASQ/CQE certification

Tools

Microsoft Office

Job description

Integra LifeSciences is seeking a Quality Engineering Manager to lead QA/QC, validation, risk management, and technical investigations in a medical-device manufacturing environment. You will partner across Manufacturing, Regulatory, Product Development, and QA to ensure compliant, robust processes and product transfers.

The role emphasizes building a strong quality engineering team, defining verification plans, and guiding CAPAs.