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Head of Quality Management

4 months ago

Mills River, United States RAUMEDIC AG Full time

We're all about life. Are you? With a headcount of approximately 1,300, RAUMEDIC is breaking new ground to improve the diagnosis and treatment of diseases. In doing so, RAUMEDIC focuses on polymer-based solutions for medical and pharmaceutical applications, as well as on products for intensive care.

Job Description

Main Tasks Responsible for all aspects of the Quality Department in Mills River Management representative Compliance with and enforcement of all procedures and practices relating to FDA regulations and ISO 13485 requirements Manager for all Quality Department staff Oversee Product Label printing and reconciliation Prepare and Manage updates to Site Quality System Procedures Administer Customer Complaint Program including performing investigations and documentation reviews Administer Corrective and Preventive Action Program Administer Non-Conforming Product Program including material disposition Manage, Schedule and Perform Internal Audits Manage, Schedule and Perform Supplier Audits Manage and support site for Customer Audits Schedule and perform quarterly microbiological studies in clean rooms Prepare and route Quarterly Environmental Report for Particulate and Bioburden Responsibility for strict observance of legal rules and regulations referring to work safety and adherence of working time Exhibit Leadership principals, leading Staff to the expectations of RAUMEDIC and the Guidelines of RAUMEDIC

Important Particular Tasks Monitoring the effectiveness of quality system in the plant Report on Goals and Key Operating Indicators Final Release of all products for shipment Provide input and support to develop, review, initiate and update Failure Mode Effect Analysis Prepare and Manage updates to Site Quality System Procedures Interface with Customer on Technical/Quality Issues and improvements in cooperation of the Business Unit Responsible for all Site Regulatory items Direct oversight of all metrology functions for production and new product validation Direct oversight of preparation of all documents required for Validations (Protocols and Reports) Schedule and perform training activities for all staff on required procedures Maintain all Training Records for Staff Act as a backup for all Quality Functions (QE, Documentation, Technician, QC Inspector) Additional duties as required

Job Requirements

Bachelor’s degree in Engineering, business or science related degree. Relevant experience may substitute for the degree requirement on a year-for-year basis. 5-10 years progressively responsible, professional engineering or Quality System experience, including three years of experience supervising or leading the work of others The ability to work flexibly, oftentimes working non-standard shift hours

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