Director - Medical Quality Compliance - Molex - Lisle

Job description
PRIMARY PURPOSE: This position is responsible for the oversight, management and implementation of the Quality and Regulatory components with the USA FDA, ISO13485 and various regulatory requirements in Europe and Asia; including all regulatory requirements for the Molex Medical Products. This position will ensure that all activities performed will be in support of Customer Service, Manufacturing, Sales, Engineering, and the Quality System by managing the following duties.

DUTIES & RESPONSIBILITIES:
1. Participate as a member of or a resource to the management team to establish overall vision, goals and strategies; oversee employee communication efforts to ensure understanding of the company’s strategic direction.
2. Responsible to assist Molex Business Units and associated Quality Representatives for Regulatory and Government activities and compliance related to Medical products or products sold to medical customers.
3. Responsible to assist in the overview, assessment and registration of Molex Product compliance to Regulatory and Government agencies.
4. Responsible to participate in compliance assessment (product and system) for product transfers to Molex International locations (i.e. Guadalajara and Thailand).
5. Provide support, direction and leadership to the Molex Quality team especially related to compliance of Medical Products.
6. Influence change in a positive manner by developing and accomplishing specific team goals; attaining group objectives by providing leadership, counseling, conducting/assisting in evaluations, staff training and problem solving
7. Responsible to train employees, departments and or suppliers in satisfying requirements of ISO13485, MDD, and the FDA or other non-US governmental regulatory body Quality System regulations and company procedures.
8. Responsible for participating in the development and implementation of quality policies and procedures within the Corporate Quality System.
9. Oversee and conduct internal audits, provide guidance and interface directly with scheduling, assigning and qualifying auditors and ensuring proper training is being followed in accordance with the regulations.
10. Updates job knowledge by studying trends in and developments in quality management; participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations.

Job Requirements
EDUCATION:
REQUIRED: Bachelor’s degree in Engineering, Science, Quality or Business Administration required.
PREFERRED: Master’s degree is preferred.

WORK EXPERIENCE:
REQUIRED:
•Seven to ten years’ experience in a management role in a medical device manufacturing environment with at least five years in a Quality or Regulatory Affairs related position.
•Experience overseeing multiple manufacturing sites located in different countries.
•Advanced knowledge of ISO13485, MDD, FDA Quality System Regulation including the relevant Title 21 CFR parts and application of risk management ISO14791.

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