Hiring an experienced Quality Manager who has worked in highly regulated manufacturing industries like food and beverage, FDA or similar. We are trying to identify someone that has driven succesful quality systems, working with continuous improvement and lean who can also collaborate well with production, engineering and sales. If you would be interested in working in Indianapolis this job could be for you. Please read through responsibilities and apply with qualified resume.

• Ensure plant compliance to 21 CFR 820 and ISO 13485 and conformance with established processes and customer requirements and expectations through management of the quality system and personnel.
• Investigate, understand and convey customer expectations through continual customer interface via customer visits, meetings and conferences.
• Manage internal audits of business unit operations systems in accordance with internal, regulatory, or customer driven requirements.
• Identify, recommend and perform quality training as needed.
• Communicate, identify and facilitate investigations into complaint issues. Approve and communicate results of investigation to customer representatives and authorize return of goods if necessary.
• Manage maintenance and control of quality measurement instrumentation, production documentation and records.
• Responsible for developing annual Quality Objectives with site leadership.
• Manage the Master Validation Plan (MVP).
• Identify needs for process controls and statistical analysis to ensure processes are stable and capable ongoing.
• Chair the Material Review Board, Trend Analysis, and CAPA board meetings for site.
• Facilitate site-oriented customer and 3rd party audits.
• Ensure segregation, containment, and disposition of nonconforming product in a timely manner.
• Manage and monitor performance of suppliers and their products supplied to our site.
• Ensure investigation and corrective actions are complete, implemented, and effective for product nonconformances, deviations, audit findings, and complaints.
• Request, interpret, and evaluate customer specifications.
• Manage the preparation and submission customer requests for data, controlled customer documents or any other requests.