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Job description

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
• Investigate and assist with nonconformance report dispositions and support of NCR's until closure
• Facilitate the corrective / preventative action (CAPA) process and supporting tools
• Responsible for the development of tracking and trending systems for quality information including Nonconforming Material, Product Returns, Complaints and Calibration.
• Promote and execute quality standards, inspection processes (including visual), test methodology, quality plans, calibration methods, documents, reports, and the eQMS documentation system
• Assist in process verification and validation, including development of testing methodology
• Review customer complaints and develop root cause corrective action responses, to include tracking and trending
• Assist in maintaining processes and documentation related to clean room requirements
• Establish supplier quality requirements and performance reporting
• Conduct or participate in the supplier quality audit process
• Compile, write, and deliver training material on quality system requirements

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.

Job Type: Full-time

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• Day shift
• Monday to Friday

Ability to commute/relocate:

• Dubuque, IA 52002: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Preferred)

Experience:

• Quality assurance: 1 year (Preferred)

Work Location: In person