1 Quality Assurance Inspector I / Assembler I Job in Prairie, MN
SORT BY
N
Quality Assurance Inspector I / Assembler I
$46k-58k (estimate)
Full Time | Medical Technology
3 Weeks Ago
Nuwellis, Inc. is Hiring a Quality Assurance Inspector I / Assembler I Near Prairie, MN
DescriptionNuwellis, Inc. is a medical device company dedicated to transforming the lives of patients suffering from fluid overload with its Aquadex SmartFlow ultrafiltration therapy.
The Quality Assurance Inspector I / Assembler I position supports both the Quality and Operations Departments (50% time in each department).
The Quality Assurance Inspector I position is responsible for assigned aspects of the Quality System to assure compliance with the Quality System Regulations (QSR), ISO, and other applicable requirements. This position will be expected to apply knowledge of quality systems to the administration and/or support of the Quality System.
The Assembler I position will use a variety of hand tools, fixtures, semi-automated equipment, test equipment, and work instruction to perform a series of operations to assemble and test medical devices.
This is an onsite position, requiring a full-time in-person presence at Nuweliis' corporate office in Eden Prairie, MN.
Essential Duties And ResponsibilitiesQuality Assurance Inspector I
WORKING ENVIRONMENT There is significant work pace & pressure due to deadlines. The employee may be required to work overtime or weekends.
The Quality Assurance Inspector I / Assembler I position supports both the Quality and Operations Departments (50% time in each department).
The Quality Assurance Inspector I position is responsible for assigned aspects of the Quality System to assure compliance with the Quality System Regulations (QSR), ISO, and other applicable requirements. This position will be expected to apply knowledge of quality systems to the administration and/or support of the Quality System.
The Assembler I position will use a variety of hand tools, fixtures, semi-automated equipment, test equipment, and work instruction to perform a series of operations to assemble and test medical devices.
This is an onsite position, requiring a full-time in-person presence at Nuweliis' corporate office in Eden Prairie, MN.
Essential Duties And ResponsibilitiesQuality Assurance Inspector I
- Serve as Manufacturing floor support for product inspection and disposition and other activities as assigned.
- Perform component and product receiving, inspection, in-process inspections, and finished goods inspection, release, and distribution.
- Perform documentation review to ensure GDP, accuracy, and completion.
- Assist with qualification/validation protocol execution.
- Assist with all Quality Systems investigations (NCMR, CAPA, SCAR, Complaint, etc.)
- Assist in complaint product processing receipt, failure analysis, and disposal.
- Assist in collecting Quality System Metrics.
- Assure all Quality System documentation and record keeping activities are carried out and completed in compliance with established procedures and work instructions.
- Follow detailed work instruction, processes and procedures to correctly assemble and test medical devices using a variety of hand tools, fixtures, semi-automated equipment, test equipment.
- Comply with policies, guidelines, and regulatory requirements per the Nuwellis Quality System.
- Complete all administrative functions relating to business or regulatory requirements.
- Report problems with quality, processes, equipment, and materials to Production Management or Engineering.
- Provide hands on job function training to coworkers as needed.
- Maintain a clean and organized work area.
- High school diploma or equivalent
- Associate’s degree in a technical field.
- Medical device manufacturing experience in a clean room environment in a regulated industry.
- Detail oriented with accurate recordkeeping skills.
- Good communication and interpersonal skills.
- Proficient in MS Excel, Word, Power Point.
- Experience with personal computers and working with microscopes.
- Organized with the ability to prioritize multiple tasks.
- Gluing and bonding experience.
WORKING ENVIRONMENT There is significant work pace & pressure due to deadlines. The employee may be required to work overtime or weekends.
Job Summary
JOB TYPE
Full Time
INDUSTRY
Medical Technology
SALARY
$46k-58k (estimate)
POST DATE
06/12/2024
EXPIRATION DATE
07/11/2024
WEBSITE
nuwellis.com
HEADQUARTERS
EDEN PRAIRIE, MN
SIZE
50 - 100
FOUNDED
1999
TYPE
Public
CEO
NESTOR JARAMILLO JR
REVENUE
$5M - $10M
INDUSTRY
Medical Technology
Related Companies
Show more
Similar Jobs
Popular Articles
Top 10 Things to Avoid Putting on a Job Application
Read Article
How to Describe Your Education in a Resume
Read Article
How to Write a Memorable Cover Letter in 5 Ways
Read Article
4 Personal Finance Tips to Make During Job Transition
Read Article
4 Best Camera Setups for Interview
Read Article
Keeping a Job Search Journal: 9 Types of Journaling You Can Do
Read Article
