Job Description

Essential Duties and Responsibilities (these are primary responsibilities of the role and the incumbent will perform other duties as assigned):

Knowledge of GMP/QSR, ISO requirements, Corporate Quality Manual (CQM), SOP's, specifications, in process and final release requirements is requisite.
The basic scope of the job and in addition, the R&QE responsibility requires the ability to determine the suitability of changes based on process, product, and regulatory knowledge.
Communication skills, both written and spoken, are needed.  This job requires that presentations, remarks and classroom instruction be done on a frequent basis.  Letters, memos, and project status reports must be generated to persons inside and outside of Baxter.
Use of direct technical and organizational management skills to start, implement, finish and sustain subordinate activity and/or behavior is requisite.
Implements and assures compliance of manufacturing and quality control operations with respect to corporate specifications, SOP’s, Good Manufacturing Practices/Quality System Regulations (FDA 21CFR 820), Corporate Quality Manual (CQM), ISO 13485-2003, EN ISO 13485-2012, Canadian Medical Device Requirements (CMDR), MDD 93/42/EEC and other applicable standards and regulations.
Assure timely release of finished products based on conformance of products to written requirements.
Manage through subordinates the coordination of the activities of a section or department in the Quality organization. Is responsible for results in terms of product quality and conformance to regulations and Baxter quality policies.
May participate in or manage quality assessments of suppliers to analyze compliance and assess risk.
Provide information on and proactive approaches to reduce internal defect levels and customer complaints.  This is accomplished through review and project assignment/priority based on customer and monitor account trend information.
Interacts frequently with subordinate supervisors and functional peer group manager.  Manages the coaching, training, and development of subordinates.
Assists in development of and manage departmental budget and annual capital budget.
Initiating action to prevent the occurrence of any nonconformities relating to product, process, and quality system.
Identifying and recording any problems relating to the product, process and quality system.
Initiating, recommending, or providing solutions through designated channels.
Verifying the implementation of solutions.
Controlling further processing, delivery, or installation of nonconforming product until the deficiency or unsatisfactory condition has been corrected.

Job Requirements (Education, Experience and Qualifications):

Minimum Bachelor's Degree preferably in Science or Engineering.
5+ years’ experience including 1-2 years supervisory/managerial.
Substantial interpersonal skills for routine interaction with Suppliers, Plant QM Manager, Quality Manager II, Production Manager, Staff, Corporate/Divisional groups and other manufacturing facilities. 
In addition, non-routine interaction will be required with FDA, TÜV and End Product Users.

Physical / Safety Requirements

Duties may require overtime work, including nights and weekends
Use of hands and fingers to manipulate office equipment is required