Director - Quality Product Surveillance & FCA - Baxter Healthcare - Round Lake

Job description
Develops and deploys the quality system for complaint handling and field corrective actions (FCAs). Assures systems and procedures for regulatory compliance are established and deployed. Periodically reviews the suitability and effectiveness of the quality system with executive management. Manages regulatory inspections for complaint handling and FCAs.

Essential Duties and Responsibilities
Manages the Product Surveillance and FCA organizations. Is responsible for conformance to regulations and Baxter policies. May act as the Management Representative for Quality
Develops and deploys the quality systems that ensure that complaint processing and FCAs conform to defined requirements
Understands and deploys processes to assure conformance to regulations. Manages regulatory inspections
Process owner for the Complaint Handling Quality System. As process owner, lead the team in development of the following: Collaboration across B/R/F to ensure process performance, engage and act upon information and challenges and identify best practice

Partner with teams to ensure alignment in identification of risks and project associated with process
Responsible for ensuring the proper training is available globally
Periodically reviews the suitability and effectiveness of the quality system with executive management
Assesses and advises senior management concerning acquisition targets
Interacts frequently with all levels of internal management as well as across functions and business units
Manages interactions with customers and regulators concerning the quality of products, systems and processes
Identifies and manages continuous improvement projects that may span multiple sections or departments with the objective of achieving quality, reliability and cost improvements
Responsible for adherence to specifications and procedures that have been established to ensure product quality in area of responsibility
Develops budget and ensures adherence to the budget
Manages overall coaching, training, development and succession plans for the team

Desired Skills and Experience
Qualifications
In depth knowledge of the regulatory environment for manufacture of medical products
Strong leadership skills and demonstrated success in managing a large team.
Strong analytical and problem solving skills
Excellent verbal and written communication skills
Success working with multifunctional, global teams
Excellent interpersonal/communication/influencing/negotiation skills required
Demonstrated problem solving skills
Education and/or Experience
BS in science or engineering; advanced degree helpful
Minimum of 10 years experience in Quality, Manufacturing or related field in the medical products industry
7 years management experience

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