Roles and 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.

• Develops process improvement plans using a variety of Quality and Continuous Process Improvement tools, including but not limited to Six Sigma, LEAN Manufacturing, 5S, SPC, 8D, engineering studies, Gauge R&R, etc.

• Ensures process efficiency and compliance effectiveness through the development and implementation of process verification and validation plans, including Master Router Plans (Site Level), Validation Router Plans (Product or Process specific plans), and the development of simple yet detailed 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, DFMEA, Fault Tree Analysis, 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.

• Performs a broad variety of tasks in support of product and process design as assigned by the departmental manager.

• This position provides process support in accordance with documented global & local QMS procedures & practices. He/she develops the strategy for the site CAPA program to meet compliance requirements and is responsible for the development, implementation and improvement of QA practices. The role may involve work in CAPA, QMS processes, RCA, design transfer, manufacturing, distribution, and service.

Required Qualifications

• Engineering bachelor's degree from an accredited university or college (or a high school diploma / GED with at least 4 years of experience in Quality).

• 1-3 years of additional years of experience in QA Engineering

Desired Characteristics

• Quality Assurance/Quality Engineering experience in the Aerospace or Aviation industry or experience in design engineering or manufacturing engineering in Aerospace, Aviation or Oil and Gas field.

• Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes

• Demonstrated expertise to effectively communicate within all levels of the organization around concepts of Repair/services controls, Repair/services verification and validation activities; production &process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement using tools such as six sigma, DFR, etc.

• Demonstrated collaboration & conflict resolution skills

• Excellent communication skills (written and oral)

• Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance

• Demonstrated understanding of product development lifecycles, design change and document change control, process verification and validation methodologies, manufacturing /production process control methodologies, and servicing in a medical device environment.

• Demonstrated understanding of continuous quality / process improvement tools: (As defined by the local site, e.g. DMIAC, SPC, Lean SS, 5S, 8D)

• Experience leading and implementing change

• Experience performing internal and external audits

• Exceptional analytical, problem solving & root-cause analysis skills

• Ability to multi-task & handle tasks with competing priorities effectively

• Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & demonstrated experience interfacing with regulators.

• Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and database applications.

•  Experience managing project teams.

The base pay range for this position is $82,000.00 - 136,700.00 USD Annual. The specific pay offered may be influenced by a variety of factors, including the candidate’s experience, education, and skill set. This position is also eligible for a 10% performance bonus/variable incentive compensation/equity. ​

*The Company pays a geographic differential of 110%, 120% or 130% of salary in certain areas.

Healthcare benefits include medical, dental, vision, and prescription drug coverage; access to a Health Coach, a 24/7 nurse-based resource; and access to the Employee Assistance Program, providing 24/7 confidential assessment, counseling and referral services. Retirement benefits include the GE Retirement Savings Plan, a tax-advantaged 401(k) savings opportunity with company matching contributions and company retirement contributions, as well as access to Fidelity resources and planning consultants. Other benefits include tuition assistance, adoption assistance, paid parental leave, disability insurance, life insurance, and paid time-off for vacation or illness.