Posted Position Title Quality Assurance Risk Manager

Job Number	1861438
Business	GE Healthcare
Business Segment	Healthcare Quality
About Us	What do you envision for your future? At GE Healthcare, we strive to see life more clearly. Our "healthymagination" vision for the future invites the world to join us on our journey as we continuously develop innovations focused on reducing healthcare costs, increasing access and improving quality and efficiency around the world. We are a $17 billion unit of General Electric Company (NYSE: GE), employing more than 46,000 people worldwide and serving healthcare professionals in more than 100 countries. We believe in our strategy - and we'd like you to be a part of it. As a global leader, GE can bring together the best in science, technology, business and people to help solve one of the world's toughest challenges and shape a new age of healthcare. GE is committed to diversity . We aim to employ the brightest minds in the world to help us create a limitless source of ideas and opportunities . We believe in hiring talented people of varied backgrounds, experiences and styles - people like you ... Something remarkable happens when you bring together people who are committed to making a difference - they do! At work for a healthier world.
Career Level	Experienced
Function	Quality
Function Segment	Quality Assurance and Regulatory Affairs
Location(s) Where Opening Is Available	United States
U.S. State, China or Canada Provinces	Wisconsin
City	Waukesha
Postal Code	53188-1696
Relocation Expenses	Yes
Role Summary/Purpose	GE is an equal opportunity employer, offering a great work environment, challenging career opportunities, professional training and competitive compensation. The Risk Manager assesses the degree of risk associated with the use of the medical devices designed and / or manufactured by GE Healthcare (GEHC). Risk Management is an integral part of the product development process over the commercial life of the product.
Essential Responsibilities	• Develop management reports to qualify and monitor risks to ensure risk responses are timely and effective • Determine the most effective methods for handling risk exposures and recommend mitigation to senior management • Decompose hazards into lower level hazards and hazardous situations • Total product lifecycle monitoring - linking product development risk management to post-market risk assessments • Identify and drive improvements to overall Risk Management processes and documentation to provide clear flow down of regulations • Educate, train, advise and coach business leaders and QA/RA practitioners on the related regulations, procedures and work instructions • Work closely with Clinical/Medical professionals to assure their input is foundational to the hazards and harm inputs to risk management • Assure probability of occurrence is consistently applied during failure investigation and risk analysis • Identify hazards and hazardous situations • Estimating, evaluate, and control associated risks • Monitoring the effectiveness of the control of risk Quality Specific Responsibilities: 1. Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position 2. Complete all planned Quality & Compliance training within the defined deadlines 3. Identify and report any quality or compliance concerns and take immediate corrective action as required 4. Ensure that specified risk management requirements are met though knowledge & understanding of GEHC Risk Management Procedures and Work Instructions; operate within them in guiding and facilitating product teams that control the design and manufacture of the device.
Qualifications/Requirements	• Bachelor’s degree in scientific / clinical discipline or engineering, and a minimum of 5 years of progressively more responsible Quality Assurance or Regulatory Affairs experience in the medical device, pharmaceutical or chemical industry; OR high school diploma/GED and a minimum of 12 years of progressively more responsible Quality Assurance or Regulatory Affairs experience in the medical device, pharmaceutical or chemical industry • A minimum of 3 years of Risk Management experience in the medical device, pharmaceutical or chemical industry, including experience facilitating risk working sessions • Experience with Risk Management standards (ISO 14971 for medical devices and ICH Q9 for pharmaceuticals) • Knowledge of risk management methods and practice, cost/benefits analysis, and risk models and project management practices • Experience with risk management tools such as FMEA, FTA, HAZOP, fish-bone diagrams, and robust design techniques • Strong analytical skills • Demonstrated knowledge of Quality Management Systems and experience linking risk management to all elements of the Quality System (Design Controls, CAPA, P&PC, Complaints, Document Control, etc) • Demonstrated experience with ISO, GxP, FDA or other key regulatory bodies • Ability to communicate effectively in English • Prior experience using word processing, spreadsheet, and presentation software • Must be willing to work out of a the Waukesha, WI office location Desired Characteristics
Additional Eligibility Qualifications	GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a background investigation and drug screen.
Desired Characteristics	• Working knowledge of ISO 14971 - Medical Device Risk Management Standards, and ICH Q9 Pharma Risk Management Standard • Demonstrated experience leading and facilitating change • Demonstrated experience working in a cross-functional environment and proven ability to influence and build consensus among multiple functions including but not limited to engineering, operations, regulatory affairs, and medical affairs • Knowledge of GEHC product family and P&L organization • ASQ Certification as Quality Engineer (CQE), Quality Manager (CQM), Operations Excellence (OE), or other related discipline • Demonstrated compliance program management/leadership experience. • Able to prioritize, plan, delegate and evaluate deliverables to established strategic goals • Demonstrated process/lean skill to drive project execution with discipline • Demonstrated collaboration, negotiation & conflict resolution skills. Ability to build a connection with the team through personal involvement & trust & providing feedback & coaching to help develop others • Visibly demonstrates comfort & efficacy in presenting to and in communicating with top organizational leadership & internal & external customers, responding in a professional manner • Familiar with classic quality tools & experienced in applying them to monitor function performance • Global regulatory experience & demonstrated experience interfacing with FDA • Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures) • Prior GEHC experience