Head of Quality Management

3 weeks ago


Mills River, United States CareerBuilder 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

Bachelors 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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