KKR Consulting · 12 hours ago
Senior Quality Engineer
Texas, United States
Contract
Hybrid
Senior Level
5+ years expKKR Consulting partners with businesses to solve challenges and achieve lasting success, specializing in tailored consulting services across various industries. The Senior Quality Engineer will support Operations to ensure adherence to Quality System requirements for medical device manufacturing and compliance with regulatory standards.
Staffing & Recruiting
Hiring Manager
Satya CH
Responsibilities
Adheres to Client Core Values and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements
Participates in the development, completion, and maintenance of risk analyses
Leads the generation and completion of protocols and reports for product, process, and test method validations
Collaborates with Manufacturing Engineers to review processes for new and existing products and supports the coordinate of process validations and capability studies
Supports the development various inspection techniques and procedures to ensure product integrity to design specifications. Responsible for the writing, implementation, and training of Incoming, In-Process, Manufacturing instructions, and Final Inspection procedures
Qualification
Required
Ability to read and write in English
Self-motivated with strong ability to adapt to change
Ability to work cross-functionally and as part of a project team
Ability to read and interpret technical drawings
A minimum of 5 plus years of Experience required
Proficiency in statistical tools (e.g., Gage R&R, Capability Analysis, ANOVA); Minitab experience is a plus
Experience in ISO 13485 industry
Ability to conduct root cause investigations using techniques such as FMEA, Fishbone, 5 Why, and 8D
Knowledge of Process Validation (IQ, OQ, PQ, TMV).(Must)
Detail-oriented with strong organizational skills
Experience in audit processes (internal or external audits)
Benefits
401K
Dental Insurance
Vision Insurance
Paid time off
Paid Vacation
Company
KKR Consulting
At KKR Consulting, we collaborate with businesses across a wide range of industries to tackle complex challenges, fuel sustainable growth, and connect them with exceptional talent.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase