Sr. Quality Engineer - Oxenham Group LLC

Our client, an innovative med device company in the north Indianapolis area, is looking for a Quality Engineer to develop, implement, and maintain quality engineering methodologies for their Class III Medical Device.

Responsibilities

• Work cross-functionally with development and operations teams to establish quality requirements at all phases of product/process development and manufacturing
• Apply regulatory requirements such QSR, MDR, ISO and participate in development and maintenance of procedures in compliance with regulations
• Work on product V&V activities including review of protocols and reports
• Work with Product Development on the Risk Management Process and maintain the Risk Management File
• Work with Operations on process validation activities including review of protocols and reports
• Technical support for Incoming Inspection including First Article Inspection
• Qualify suppliers, maintain the Approved Suppliers List (ASL) and associated files, and manage Supplier Corrective Action
• Provide technical support for the Non-Conforming Material system, including review of dispositions and associated actions
• Assist with internal and external audits, including hosting auditors and developing responses to findings

Skills and Experience

• BS degree in Engineering or Chemistry related discipline
• 5 to 8 years' experience in industry
• Experience in a Quality role in the medical device or aerospace industries
• Proficiency with statistical analysis is a plus