Job Overview

The position of the QE Program Manager is responsible for leading programs and cross-functional teams through complex QE programs targeting in built predictability, efficiency, and compliance. Meanwhile, championing platform product development, process development, product care through the application of Quality Engineering skills. QE Program Manager manages activities, allocated resource capabilities, schedules, budgets and KPIs. Ensures companywide communication to facilitate on schedule, within budget successful activities completions. QE Program Manager works multi-disciplinarily, has innovative mindset, development skills with quality mindset, reduces risks and improves efficiencies from product/process inception through product launch, scale-up and maintenance to ensure products meet quality standards, customer requirements, spirit of design control process for medical devices.

Main Responsibilities

• Represents Quality Engineering Program Management in Product Lifecycle Teams

• Plays an effective role as Quality Engineering PM in Product Lifecycle Management Team, including defining, developing, promoting design control, production/process control, and risk management processes that meets applicable regulatory (local and international), Corporate/Business, Customer, and Local QMS requirements.

• Provides inputs and criticality/risk evaluation of quality, technical and regulatory requirements to Product Lifecycle Team

• Identifies trends in product performance and systemic improvements. Allies with cross-functional team on the implementation plans

• Interfaces with customers, suppliers, and various company departments to resolve quality problems and develop strategic quality improvement activities

• Develops quality strategies and plans in support of execution of quality engineering program/business plans and meeting performance targets

• Provides input for the development of company business and QMS processes to support growth

• Continuously works to improve the efficiency of Product Development, Design Controls (Quality by Design), Risk Management, Control Planning processes to ensure the outcome satisfies both user expectations and business objectives

• Provides quality technical management and leads performance improvements utilizing quality frameworks i.e., Early Quality Involvement and Design for Six Sigma (DFSS), Lean, Advanced Product Quality Planning (APQP), Variability identification and reduction in designs, processes, systems etc.

• Responsible for organizing, analyzing, summarizing data and respective findings/conclusions

• Establishes governance that promotes collaboration, prioritization, and control, identifies and request required support for QE Programs.

• Regularly communicates the status of projects with stakeholders

• Responds to the company needs, manages training programs Supports the development of training quality engineering, quality compliance, quality leadership talents with the right skills sets for programs supporting product life cycle management

• Coaches SHL employees in application of LEAN, DFSS tools and techniques in projects (Green/Black Belt)