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Supplier Quality Engineer - On-site Cleveland, MS - Contract
Job Description:
• Follow up on supplier audits to demonstrate supplier controls required by FDA CFR 820, ISO 13485 and ISO 9000.
• Works with suppliers to find solutions to identified problems.
• Create written reports and communicate the results clearly and effectively to the auditee and Baxter management.
• Manage and insure timely implementation of supplier Corrective Action Reports (SCARs).
• Provide engineering support for nonconforming material (NMR) and Return Material Authorization (RMA) issues.
• Remediate Supplier files to support current and business development activity related to acquisition of new businesses.
• Remediate SNC Process
• Verify supplier files are maintained and documented appropriately.
• Provide supplier metrics to management.
• Lead the supplier approval process by assessing manufacturing, Quality Systems capabilities and risks.
• Develop Improvement plans for Critical to quality suppliers.
• Manages personnel to maintain and reduce the Incoming Inspection cycle time.
• Establishes problem solving strategies and work with Manufacturing and Quality Engineers to reduce MRB inventory
• Perform component characteristic analysis to determine inspection status changes.
What you'll bring
• Knowledge of FDA CFR 820, ISO 13485 and ISO 9000 requirements, strongly desired ISO 13485 Lead Auditor certification.
• B.S Degree in Engineering required.
• 5+ year qualifying experience, including previous experience with quality auditing, specifically supplier audits. Excellent documentation, communication and excellent problem-solving skills desirable.
• Oral and written communications in English
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.