Manager, Quality Engineering

Job Description

Serve as Quality Engineering Manager and subject matter expert for medical device products and associated manufacturing processes. This position is responsible for managing Quality Engineers and collaborating with internal departments and external contract manufacturing organizations (CMOs) to ensure compliance. Additionally, this position shall lead and support process excellence activities and ensure effective implementation of improvements on identified projects / systems. Provide similar support for quality events, CAPAs, and audit records in eQMS. Provides audit and inspection support.

Job Requirements

Skills : Excellent communication, presentation, time management, cross-functional collaboration skills; attention to detail, multi-tasking, experience in medical devices, and strong computer skills (Word, Excel, PowerPoint, Minitab).

Extensive experience in :

• Quality with respect to manufacturing and design
• Validation
• Design Control
• Data Analysis and Statistical Techniques
• Investigations and Root Cause Analysis
• CAPA and NC
• Lean Six Sigma tools

Experience : 10+ years in a similar role is strongly preferred, in cGMP, medical device, or regulated industry (including QA or engineering experience). Management / mentorship of personnel preferred.

Education : BS in Science, Engineering, or equivalent combination of Education, Experience and Competencies.

Preferred MS in Science, Engineering, or other related discipline

Preferred Certified Six Sigma Blackbelt or ASQ Certified Quality Engineer

Job Responsibilities

Job Responsibilities :

Job Benefits

Job Benefits :

Disclaimer :

The included statements are intended to describe the general nature and level of work being performed by employees assigned to this classification.  They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.