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Quality Assurance Inspector I
2 months ago
Nuwellis, 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 RESPONSIBILITIES
Quality 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.
Assembler I
- 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.
MINIMUM QUALIFICATIONS
- High school diploma or equivalent
PREFERRED QUALIFICATIONS & COMPETENCIES
- 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.
PHYSICAL DEMANDS
The employee must frequently lift up to 25 pounds (up to 5 hours per day for Assembler I duties), and infrequently lift/move up to 50 pounds.
WORKING ENVIRONMENT
There is significant work pace & pressure due to deadlines. The employee may be required to work overtime or weekends.
