Manager, Quality Engineering

Location: Northern

## Manager, Quality Engineering Apply:
US-NJ-Plainsboro-105-Facility:
Full time:
Posted Today:
JR-6684

Changing lives. Building Careers.

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.
** SUMMARY DESCRIPTION
** 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.
** SUPERVISION RECEIVED
** Under direct supervision of the Director, Quality Operations, with collaboration with site leadership to establish project objectives and priorities.
** SUPERVISION EXERCISED
** Works independently with minimal supervision and supervises a staff of quality engineers and support staff.
** DISCRETION & LATITUDE
** The Manager, Quality Engineering assesses technical and quality data, establishes engineering priorities, provides technical direction to staff, and escalates significant product, process, compliance, and business risks to management for review.
** ESSENTIAL DUTIES AND RESPONSIBILITIES
** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Primary responsibilities are to:
* 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.
** DESIRED MINIMUM QUALIFICATIONS
**
* Education:

BS degree in Engineering or Science;…