Quality Assurance Engineer - Dubuque, United States - Access Dubuque

Description

Quality Assurance Engineer

The Metrix Company
1 Positions

ID: 44624

Posted On 03/05/2024

Job Overview

The Metrix Company, a leading medical device manufacturer, is seeking an experienced Quality Assurance Engineer to assist in maintaining the company's Quality Management System.

Responsibilities

• Assist in the review and development of standard operating procedures which support quality and regulatory compliance to standards, customer requirements, and objectives
• Supports engineering efforts by participating in design development projects representing quality assurance and the customer
• Investigate and assist with nonconformance report dispositions and support of NCR's until closure
• Participates in the corrective / preventative action (CAPA) process, as assigned. Support the Quality Assurance Manager in oversite of the system and meeting objectives around completion and effectiveness.
• Responsible for the development of tracking and trending systems for quality information including Nonconforming material (NCR's), Product Returns (RGA's), customer complaints and calibration. Works to effectively drive to closures these quality information processes.
• Promotes and executes quality standards, inspection processes, test methodology, quality plans, calibration methods, documents, reports and the eQMS documentation system
• Assists in process verification and validation, including development of testing methodology.
• Reviews customer complaints and works with engineering and production to develop root cause corrective action responses, to include tracking and trending.
• Develops, executes, and analyzes quality reporting measures, reports issues and trends to management
• Assists in maintaining processes and documentation related to clean room requirements
• Reviews suppliers' corrective actions and non-conformances and establish supplier quality requirements and performance reporting
• Assists in the development, training, and execution of internal audits; participates as an active member of the audit team
• Conducts or participates in supplier quality audit process
• Interfaces with supplier and customer quality representatives concerning nonconformance with products or processes and assure that effective corrective action is implemented.
• May compile, write, and deliver training material on quality system requirements

Acts as backup to the Quality Assurance Manager or Quality Control Supervisor in their absence, as defined in the Quality Manual.

Qualifications
Bachelor of Science degree in Chemical, Biomedical, Mechanical or Industrial Engineering / Technology or related field
A minimum of 1-3 years proven experience in quality engineering, quality control or regulatory affairs
Strong understanding of a Quality Management System, such as ISO 13485 or ISO 9001
External auditing experience is strongly preferred
Good knowledge of MS Office and databases
Great attention to detail and a results driven approach

The Metrix Company offers an excellent compensation and benefits package, including health, dental, optical, life, and disability insurance, as well as a 401k and Profit Sharing Plan.

Candidates must be authorized to work in the United States. Employer will not sponsor applicants for work visas.
Primary Contact
12799
Karen Smith
Human Resources,

Phone
Phone
Phone
Fax

Email
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False
True

Job Details
Categories
Architecture/Engineering/Drafting
Environmental/Quality Assurance/Safety
Industrial
Manufacturing
Location
Dubuque, IA
Shift
First Shift
Job Type
Employee
Full/Part
Full Time
Benefits
Health Insurance
Dental Insurance
Vision Insurance
Life Insurance
Retirement Plan
PTO (Paid Time Off)
Paid Holidays

Qualifications
Education
Bachelors
Experience
1-2 Years
Company ID
1277
Job REQ #
\# Positions
1
Start Date

End Date

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The Metrix Company

About the Company
The Metrix Company, incorporated in 1964, is an ISO 13485 and FDA-registered medical device manufacturer.

Metrix is globally positioned to meet specialty and high-volume product demands with ISO Class 8 cleanroom manufacturing in Dubuque, Iowa and San Cristobal, Dominican Republic.

Metrix serves a variety of markets, including medical device, biopharmaceutical and veterinary industries. The product line consists primarily of single use devices, collection bags, waste bags, TPN and enteral nutrition bags.

Our design, quality and production teams have decades of experience in radio frequency welding, heat sealing, assembly and packaging to ensure the highest quality products.

We appreciate your interest in employment opportunities at The Metrix Company. As a family-owned business, Metrix employs a dedicated staff who provide support for both of our manufacturing facilities. If you are energetic and quality driven, with a proven record of success, we want to hear from you