QA Engineer II - Full-time

Description

Medline Industries is the largest privately held manufacturer and distributor of healthcare supplies in the United States, providing more than 350,000 products that serve the entire continuum of care. Our innovative products and programs can be found in most hospitals, extended-care facilities, surgery centers, physician offices, home care dealers, home health agencies and retail outlets.

The Quality Engineer will be responsible for proactive hands on participation in developing, implementing, and improving manufacturing processes with focus on product quality, raw material quality, supplier quality and quality control requirements in compliance with ISO 13485-2003 quality management system standards and FDA-QSR.

This position will provide Quality Engineering support to manufacturing, helping to ensure delivery of the highest quality product to the customer. They will also be expected to assist with supporting the product development teams to ensure development of highest quality new products.

Finally, the Quality Engineer will develop Process Monitoring Systems by identifying critical process steps applying methods to reduce process variation in order to reduce/eliminate the cause of defects.

Job Duties also include:

• Leads process improvement efforts in Manufacturing by identifying methods to capture quality metric data and by performing appropriate analysis methods to enhance sustaining product design and new product development.
• Identify and recommend testing equipment and train QA Technicians on use of testing equipment; proper testing technique. Responsible for measuring and test equipment calibration and equipment maintenance programs.
• Assist in product testing and evaluation of nonconforming product. Assit with follow-up on Nonconforming Product Retentions (NPR), CAPA, and Complaint Investigations.
• Initiate and lead project teams on Corrective Action/Preventive Action (CAPA) projects. This includes, implementing the plan, and submitting a summary report for project closure and conduct effectiveness verification checks, but is not limited to, performing risk analysis, root cause analysis; developing a corrective action plan.
• Strong working knowledge of Good Manufacturing Practices (GMP) in an FDA regulated Manufacturer. Perform internal quality audits to ensure compliance to QSR/FDA and ISO 13485:2003
• Prepare and execute validations, technical studies, test method validations and other studies/reports as required. This includes preparation of protocols, establishment of test methodology and acceptance criteria, training personnel, execution, data analysis, investigation, and writing final reports.
• Perform basic dimensional, visual inspection, and testing of finish product and incoming raw materials and document appropriately.
• Assist with quality concerns as it relates to customers and/or sales representative feedback.
• Write inspection and test procedures for in-process and finished goods testing.
• Quality Management designee in absence of Quality Manager; Other tasks as assigned by Manager.
• Some travel required.

Qualification

The required skills for this position are:

• BS in Engineering or Science field required plus a minimum of 3 to 5 years of related work experience. ASQ Certified Quality Engineer is a plus.
• Previous experience with high speed manufacturing required. Automated manufacturing processes a plus.
• Previous experience with validations including writing and executing protocols and final reports. Proficient in Auto-CAD, Solidworks or ProE software is a plus.
• Advanced statistical analysis and analytical skills, detail oriented and excellent verbal and written skills.
• Self-starter, motivated and ability to work unsupervised.
• Previous experience in medical device manufacturing design/testing preferred.