Quality Specialist 2 - Life Sciences Quality

Job description

3058639
City

Logan
Career Level

Experienced
Relocation Assistance

No
Business

GE Healthcare
Business Segment

Healthcare Quality
Function

Quality
Country/Territory

United States
U.S. State, China or Canada Provinces

Utah
Postal Code

84321
Role Summary/Purpose

This role is responsible for providing manufacturing and/or engineering process support in accordance with documented procedures and practices. Responsible for the development, implementation, improvement and continuous reinforcement of established Quality Assurance fundamental practices that are utilized in the local business.
Essential Responsibilities

·  Responsible for ensuring 100 percent quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility.
·  Responsible for the development, implementation, and continuous improvement of process effectiveness and efficiency at the site. 
·  Review and access a variety of Quality and Continuous Process Improvement tools, including but not limited to Six Sigma, LEAN Manufacturing, 5S, SPC, engineering studies, DOE, Gauge R&R, etc. 
·  Ensures compliance effectiveness through the development and implementation of process verification, and the development of process flow diagrams that describe critical process inter-dependencies with respect to process inputs, outputs, risks and impacts. 
·  Supports continuous product and process improvement through detailed failure analysis for non-conformance, and investigates, develops and implements effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions (CAPA Program). 
·  Develops risk management tools and aids for use by the organization in accordance with documented procedures, including but not limited to PFMEA, Failure Mode Analysis, etc. Supports design mitigation efforts. Develops process mitigation plans and strategies that are designed to mitigate the risks identified through the Risk Management process. 
·  Ensures process compliance through the development of simple yet comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process related documentation.
·  Reviews Production and Quality documentation for adherence to Good Documentation Procedure requirements. 
·  Performs a broad variety of tasks in support of product and process design as assigned by the departmental manager.
Qualifications/Requirements

·  Bachelor’s degree (or high school diploma/GED plus 4 years working experience in Quality Engineering or Quality Assurance Management. 
·  Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485
·  Demonstrated understanding of product development life cycles, design change and document change control, process verification and validation methodologies, manufacturing /production process control methodologies, and servicing in a medical device environment. 
·  Significant Multi-Modality Sites: Minimum 4 years Quality Assurance/Quality Engineering experience in the medical device or pharmaceutical industry 
·  Small and Simple Sites: Minimum 3 years Quality Assurance/Quality Engineering experience in the medical device or pharmaceutical industry
·  Demonstrated experience using word processing, spreadsheet, and presentation software
·  Demonstrated understanding of continuous quality / process improvement tools: (As defined by the local site, e.g. DMIAC, SPC, Lean SS, 5S,) 
·  Ability to communicate using English (or local language) 
·  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. 
·  Complete all planned Quality & Compliance training within the defined deadlines. 
·  Identify and report any quality or compliance concerns and take immediate corrective action as required 
·  Meet NPI program milestone dates while approving compliance status of each 
·  Ensure 100% completion/closure of all SPRs/risks before product release to market
·  Ensure 100% on time CAPA closure for engineering investigations
Desired Characteristics

·  Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies and in-depth understanding of site level products and related processes 
·  Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production and process controls; Corrective and Preventive Action (CAPA), complaints and risk management; and product quality improvement using tools such as six sigma, DFR, etc.
·  Demonstrated collaboration, negotiation and conflict resolution skills
·  Excellent oral communication and report, business correspondence and procedure-writing skills 
·  Demonstrated ability to lead, acknowledge, develop, communicate and implement a strategy under crisis situations to ensure compliance 
·  Change agent with energy, passion and enthusiasm to drive change 
·  Exceptional analytical, problem solving and root-cause analysis skills 
·  Ability to multi-task and handle tasks with competing priorities effectively 
·  Accepting and adhering to high ethical, moral and personal values in decisions, communications, actions and when dealing with others 
·  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
·  Inclusiveness: Energizing others by building a connection with the team through personal involvement and trust, as well as providing feedback and coaching to help develop others 
·  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
About Us

GE is the world's Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry.
GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is anEqual Opportunity Employer . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
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 drug screen.