Manager, Quality Engineering

Integra LifeSciences•Plainsboro Township, NJ

1d•$109,250 - $149,500

About The Position

The Manager, Quality Engineering leads Quality Engineering support for manufacturing, product development, process improvement, validation, risk management, and technical issue resolution. The role ensures that products and processes are developed, validated, transferred, maintained, and improved in compliance with company procedures and applicable regulatory requirements. The Manager provides Quality Engineering partnership and technical expertise for nonconformances, CAPAs, customer complaints, and other cross-functional quality activities.

Requirements

BS degree in Engineering or Science
7-10 years of quality assurance engineering, manufacturing engineering, validation, reliability, or related experience supporting manufacturing
Excellent written and verbal communication skills.
Working knowledge of GMP, Quality Engineering, validation, risk management, and applicable Quality System requirements
Demonstrated knowledge of FDA GMPs, ISO 9001, ISO 14971, ISO 13485, company policies and procedures, validation guidance, and other applicable standards.
Demonstrated ability to think strategically, lead technical teams, manage priorities, and collaborate across functions.
Ability to use a computer, telephone, and general office equipment.
Strong computer skills and familiarity with Microsoft Office applications are required.

Nice To Haves

ASQ/CQE certification strongly preferred.
product-development experience is a plus.
medical-device industry experience strongly preferred.

Responsibilities

Maintain a thorough understanding of applicable requirements and standards, including FDA GMPs, ISO 9001, ISO 14971, ISO 13485, MDSAP company policies and procedures, validation guidance, and other applicable standards.
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.
Perform other related duties as necessary.