Job description

Viant is a global strategic manufacturing partner that helps medical device OEMs bring complex medical devices and components to market. Our deep materials expertise, combined with our experience in design, manufacturing, assembly, and packaging, allow us to bring our customers’ medical technology solutions to life. With nearly 6,000 associates across 24 locations worldwide, we are the perfect combination of big company scale and small company attention. For more information, visit www.viantmedical.com

The successful Quality Engineer will handle the following:

• Adhere to all quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, and other regulatory requirements.
• Support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
• Lead and implement various product and process improvement methodologies.
• Review the adequacy and correctness of changes to Bill of Materials (BOM’s), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc.
• Lead in the completion and maintenance of risk analysis.
• Lead generation and completion of protocols and reports for test method validations.
• Interface with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies.
• Develop various inspection techniques and procedures to ensure product integrity to design specifications.
• Responsible for the writing, approval and implementation of Incoming, In-Process and Final Inspection procedures.
• Ensures that the disposition of non-conforming materials meet all necessary regulatory requirements and assure adequacy of corrective actions to prevent re-occurrence.
• Lead and manage complaint investigations.
• Act as a lead in plant CAPA activities.
• Coordinate and lead preparation of Quality Plans including inspection, test and gauge requirements for new product introductions.

The successful candidate will have:

• 3+ years’ experience in medical device or other regulated manufacturing industry Bachelor’s Degree in related field.
• Requires ability to multitask, lead, and drive initiatives to completion, competence in the selection and use of Quality Engineering Tools and Techniques.
• Strong communication skills and ability to align with key stakeholders.

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