KKR Consulting · 3 hours ago
Quality Engineer
Marlborough, MA
Full-time
Onsite
Mid LevelKKR Consulting is seeking a Quality / Process Validation Engineer to support manufacturing and quality initiatives in a regulated medical device environment. This role will focus on process validation execution, statistical analysis, and cross-functional collaboration to ensure products and processes meet internal and regulatory requirements.
Staffing & Recruiting
Hiring Manager
Dyutipriya Sarkar
Responsibilities
Lead and support Process Validation activities including IQ, OQ, PQ, and TMV •(Must have)•
Conduct root cause investigations using:
FMEA
Perform statistical analysis using tools such as:
Gage R&R and 8D
Capability Analysis
ANOVA
(Minitab experience is a plus)
Read and interpret technical drawings, specifications, and manufacturing documentation
Support audit readiness and participate in internal/external audits as needed
Create, review, and maintain documentation aligned with ISO 13485 and medical device compliance requirements
Ensure corrective and preventive actions (CAPA) are properly documented, executed, and sustained
Drive continuous improvement initiatives to improve quality, yield, and compliance
Qualification
Required
Ability to read and write in English
Strong self-motivation with the ability to adapt to change in a fast-paced environment
Ability to work cross-functionally and as part of a project team
Ability to read and interpret technical drawings
Experience in ISO 13485 regulated industry
Strong attention to detail and organizational skills
Hands-on experience supporting audit processes (internal or external audits)
Strong knowledge of root cause investigation tools (FMEA, Fishbone, 5 Why, 8D)
Process Validation experience (IQ/OQ/PQ/TMV)
Preferred
Minitab experience is a plus
Benefits
Medical insurance
Vision insurance
Dental insurance
401(k)
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