1. Perform root cause analysis and implementation of corrective action on process and product failures.
2. Identify and report product/process trends; perform database queries, and develop summary reports and charts.
3. Assist Quality Manager in establishing, implementing and maintaining the Quality Management System.
4. Support the Quality Inspectors to ensure that products and processes comply with the relevant requirements of the quality management system.
5. Conduct audits, including closing out audit findings, creating audits finding reports and determine proper corrective and preventive actions.
6. Perform and analyze product and process failure.
7. Manage the nonconforming material system.
8. Create and maintain company quality procedures.
9. Formulation of test procedures.
10. Improving QA receiving inspection process and procedures.
11. Ensure timely resolution of supplier failure, corrective actions and preventive actions.
12. Manage suppliers’ performance, CAPA activities and conduct audits.
1. Handle various projects and responsibilities simultaneously and successfully meet deadlines.
2. Use computer skills in Microsoft Excel//Word, including pivot tables and charts/graphs.
3. Work with other groups or individuals to resolve issues.
4. Other duties as assigned with or without accommodation.
5. All employees are expected to pay attention to and work in support of a safe and healthy work environment. This includes following the established rules, policies and practices of environmental, health and safety with specific attention to the Medtronic Cardinal Rules.
Must Have: Minimum Qualifications
Education: Bachelor’s degree in a technical field or relevant discipline from an accredited four year college or university preferred
Experience: Minimum of 3 years of related Quality Assurance technical experience in a medical device manufacturing facility.
Nice to Have:
Ability to troubleshoot with customers regarding device repairs, and explain product characteristics.
• Medical device experience required.
• Strong knowledge of failure investigation principles.
• Proven analytical and problem resolution skills
• Ability to understand, interpret, and explain technical issues with medical devices.
• Proven ability to calculate figures or amounts.
• Computer literate with working knowledge of Word, databases, and spreadsheets.
• Excellent written and oral communication skills.
• Demonstrates good attention to detail and accuracy.
Other Skills: • Ability to work effectively with diverse groups and individuals.
• Ability to work with normal production tools and equipment.
• Ability to work with test and documentation equipment.
Position reports to the Quality Assurance Manager. The Operations Quality Engineer II will work primarily with engineers, manufacturing, service, and other disciplines and sites as required.
Normal office conditions with routine visits throughout the warehouse, receiving and shipping areas. These areas include hazards for temperature fluctuation and light machinery such as forklift traffic. While performing the duties of this job, the employee is regularly required to sit, talk, hear and use hands and arms to reach. The employee is occasionally required to stand, walk, lift and use hands or fingers to handle office equipment, controls or to feel objects. Specific vision abilities required by this job include close vision and ability to adjust focus. The noise level in the office environment is low to moderate; in the warehouse areas, noise level may be moderate to high for short periods.
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