Overview
On Site
Full Time
Skills
Mergers and Acquisitions
Report Writing
Art
MRB
Manufacturing Engineering
Routers
Bill Of Materials
Product Development
Inspection
Regulatory Compliance
Management
Auditing
Problem Solving
Conflict Resolution
ROOT
Data Analysis
Medical Devices
Testing
Design Of Experiments
Analysis Of Variance
Minitab
ISO 13485
Microsoft Word
Microsoft Excel
Manufacturing
Mechanical Engineering
Assembly
ESD
Cabling
Test Methods
Documentation
Reporting
MASS
Job Details
Location: Marlborough, MA
Salary: Negotiable
Description: Our client is currently seeking a Sr. Quality Engineer - Medical Device
Onsite in Marlboro, MASS
Must Have E/M Assembly type experience
Will support Manufacturing
Report writing and protocols
Root cause
Collection action activity
MUST have Class II (preferred) or Class III Medical Device experience THIS IS A MUST HAVE
We are focused on developing next-generation medical products based on its state-of-the-art technology.
Responsibilities:
Requirements
Contact:
This job and many more are available through The Judge Group. Please apply with us today!
Salary: Negotiable
Description: Our client is currently seeking a Sr. Quality Engineer - Medical Device
Onsite in Marlboro, MASS
Must Have E/M Assembly type experience
Will support Manufacturing
Report writing and protocols
Root cause
Collection action activity
MUST have Class II (preferred) or Class III Medical Device experience THIS IS A MUST HAVE
We are focused on developing next-generation medical products based on its state-of-the-art technology.
Responsibilities:
- Support Material nonconformance investigation and disposition activity, participate in weekly MRB meetings, follow-up on supplier issues
- Assist with maintenance of calibration system
- Support Manufacturing Engineering in the creation, release and maintenance of DHR, routers, bills of material, and specifications for manufacturing
- Support Product development activities and design transfer into manufacturing
- Perform incoming inspection review and disposition of product components and subsystems
- Develop and/or revise routine procedures, work instructions, and test methods.
- Document all activities in compliance with applicable medical standards, regulations, and guidelines.
- Assist in investigations of quality issues arising from product complaints, CAPAs, and non-conforming reports.
- Support management of new and approved suppliers; participate in internal and supplier audits.
- Utilize problem solving tools to analyze and identify root causes and implement corrective actions.
- Make decisions and propose solutions based on calculated risks identified through data analysis.
Requirements
- 5 - 10 years of manufacturing quality experience within the medical device industry.
- Working knowledge of advanced statistical methods (e.g., hypothesis testing, DOE, ANOVA, R&R studies, capability, tolerance interval analysis, power and sample size determinations, etc.), including statistical software tools, such as Minitab, is preferred.
- Extensive working knowledge of 21 CFR 820 and ISO 13485.
- Strong working knowledge of Microsoft Word and Excel.
- Hands-on experience with any of the following manufacturing processes: Electro-mechanical assembly, ESD controls, Cabling, Clean room, Labeling, sterilization.
- Experience executing process validation and test method validation/Gage R&R activities.
- Strong documentation capability for protocol and report generation and review.
- Prior start-up experience is a plus.
- Must be onsite in Marlborough, Mass
Contact:
This job and many more are available through The Judge Group. Please apply with us today!
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