GE Healthcare provides transformational medical technologies that are shaping a new age of patient care. GE Healthcare’s expertise in medical imaging and information technologies, medical diagnostics, patient monitoring and life support systems, disease research, drug discovery, and biopharmaceutical manufacturing technologies is helping physicians detect disease earlier and to tailor personalized treatments for patients.
GE Healthcare offers a broad range of products and services that are improving productivity in healthcare and enhancing patient care by enabling healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases, and other conditions. Headquartered in the United Kingdom, GE Healthcare is a $15 billion unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 46,000 people committed to serving healthcare professionals and their patients in more than 100 countries.
GE is an equal opportunity employer.
Role Summary/Purpose
The Quality Assurance Leader will manage quality systems, processes, and procedures to assure product safety and quality by driving business alignment to correct industry requirements and business objectives by managing quality system design, controls, and continuous improvement.
Essential Responsibilities
·Accountable for assisting the Asia Pacific Quality Assurance Director in leading QMS deployment and implementation
·Responsible for managing quality systems, processes and procedures to assure product quality and safety
·Support ISO certification activities to ensure maintenance of certificates, ensure/follow-up/implement corrective actions that are raised by deviations, internal audit or regulatory inspection.
·Responsible for engaging strong intradepartmental and cross-functional/organizational relationships to drive Quality System Requirements (QSRs)
·Owning the development and maintenance of policies and procedures for departmental functions
·Influencing Region compliance to Quality policy, Quality Management System procedures, and Quality Star guidelines
·Influencing participation in compliance to internal and external regulations
·Influencing quality system metrics such as Corrective and Preventive Action, training metrics, completion and complaint resolution metrics
Qualifications/Requirements
1.Bachelor’s degree (or high school diploma/GED plus 4 years experience work experience)
2.3 years experience working in a regulated medical device or pharmaceutical environment, quality control/assurance, or regulatory assurance
3.Ability to effectively communicate using English
Desired Characteristics
1.Demonstrated experience in the medical device or pharmaceutical industry and knowledge of quality system regulations and policies
2.Demonstrated ability to develop & lead process implementation & improvement in a team environment
3.Experience with some or all of the following:
ØDesign controls, design verification and validation activities
ØProduction and process controls
ØCAPA, complaints and risk management
ØUnderstanding of product quality improvement using tools such as Six Sigma, DFR
ØExperience performing internal audits
4.Demonstrated effective interpersonal and networking skills
5.Prior experience using word processing, spreadsheet, and presentation software
6.Demonstrated ability to successfully comprehend & carry out/execute actions
7.Effective oral and written communication skills
8.Analytical & problem-solving skills/root-cause analysis
9.Exceptional conflict-resolution skills
10.Ability to interface with top organizational leadership and internal and external customers, responding in a professional manner
11.Ability to prioritize and drive multiple programs
12.Integrity: Accepting and adhering to high ethical, moral, and personal values in decisions, communications, actions, and when dealing with others
13.Accepting constructive criticism and dealing calmly and effectively with high-stress situations. This includes continuing to persevere and remaining calm in challenging or frustrating circumstances
14.External Focus: Understanding customer needs, marketplace dynamics, industry trends, and the competitive landscape in the industry/function and considering the external impact of business activities and decisions on the external environment
15.Inclusiveness: Energizing others by building a connection with the team through personal involvement and trust and providing feedback and coaching to help develop others
16.Clear thinker: Simplifying strategy into specific actions with clear accountability, making decisions with speed and accuracy based on best available information, and communicating priorities clearly and concisely
