Job Description Summary
The Senior Quality Assurance Manager, QMS Integration role will be responsible for driving the GE HealthCare Quality Management System integration to ensure harmonization and optimization for the newly acquired MIM Software company. This will include ensuring alignment of procedures to assure product safety, quality, and site compliance by driving business alignment to industry requirements.
Job Description
Roles and Responsibilities
- GEHC only creates a Quality culture by driving compliance activities around a specific product, site or region. This includes being responsible for the total quality management system for the business and driving Quality metrics. Ensures quality and regulatory compliance while driving process effectiveness and efficiency. Represents GE Healthcare to external agencies and champions the evolution of the quality culture which includes executing and driving quality objectives, metrics, reporting and operating mechanisms.
- In partnership with the GEHC and MIM Software leadership team, responsible for creation and execution of the GE Healthcare Quality Management System (QMS) integration plan to ensure harmonization and optimization for the MIM Software products to assure product quality and safety.
- Identifies critical path decisions, makes recommendations, and influences / buy-in from segment leadership and business process owners to maximize QMS integration, compliance and effectiveness.
- Owns all project risk; including time and scope, and the associated plans to contain and/or mitigate risk.
- Coordinates Operational Reviews working across the organization to ensure targeted outcomes are achieved.
- Leads alignment of MIM Software quality metrics to GEHC.
- Supports external and internal audit activity as needed.
Required Qualifications
- Bachelor’s Degree in a scientific discipline; and a minimum of 10 years working experience in the medical device industry and/or regulated industry
- Demonstrated understanding or aptitude in Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.
- Requires periodic domestic and international travel.
Desired Characteristics
- Masters Degree in Science or Business Administration
- Demonstrated ability to develop & lead process implementation & improvement in a team environment
- Demonstrated ability to drive improvements in a regulated environment. Strong change management skills
- Experience with some or all of the following: Design controls, design verification and validation activities; Production and process controls; CAPA, complaints and risk management
- Experience performing internal audits
- Energizing others by building a connection with the team through personal involvement and trust and providing feedback and coaching to help develop others
- 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
- Demonstrated effective interpersonal and networking skills
For U.S. based positions only, the pay range for this position is $115,360.00-$173,040.00 Annual.
Relocation Assistance Provided: NoExplore Location
