Director - Quality Systems and Regulatory Compliance - Molex - Lisle

Job description
1. Participate as a member of or a resource to the company or divisional management teams to establish overall vision, goals and strategies to oversee employee communication efforts to ensure understanding of the company’s strategic quality regulatory compliance strategy and direction.
2. Responsible to participate in quality regulatory compliance assessments (for both products and systems) for product transfers to/from internal and external locations.
3. Participate, support and provide direction and leadership to Molex quality and operations teams with a key focus as the subject matter leader on medical products and other industries with regulatory requirements.

4. Influence change in a positive manner by developing and accomplishing specific team goals and attaining group objectives by providing leadership, mentoring, counseling, and conducting/assisting in evaluations, employee training and problem solving.
5. Responsible to train employees and or suppliers in satisfying requirements of ISO13485, Medical Device Directive, and the FDA or other non-US governmental regulatory body quality system regulations, customer and industry requirements and company procedures.
6. Responsible for participating in the development and implementation of quality policies and procedures within the corporate quality management system.
7. Oversee and conduct internal regulatory mock audits, provide guidance and interface directly with scheduling, assigning and qualifying auditors and ensuring proper training is being followed in accordance with regulations, standards and specifications.
8. 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.
9. Advise the company on the regulatory aspects that would affect proposed activities.
10. Serve as primary internal regulatory advisor responsible for facilitating all regulatory agency interactions by working with all plants and divisions globally.
11. Lead global submittals of regulatory information to relevant regulatory authorities in support of product license and registration renewals as well as new registrations.
12. Interact with regulatory authorities on project related issues, marketed product authorizations, regulatory policies and other relevant issues.
13. A critical aspect of this role is to build partnerships with the all Molex sites and provide expert advice with an overall goal of maintaining a high level of global quality system compliance. Lead coordinated global compliance to quality system standards and regulations.
14. Define, communicate and gain cross functional and cross-divisional support for the quality system and compliance strategy to mitigate product and compliance risk.
15. Lead or assist facilities in the formulation and execution of remediation efforts resulting from compliance inspections including responses and implementation follow up.
16. Understand, support and contribute to current Molex Total Quality Management (TQM), Six Sigma, International Standards Organization (ISO) and Environmental, and/or Health and Safety (EH&S) Management Systems by following stated policies and procedures.
17. Perform other related duties as assigned by management.

Job Requirements
• Previous experience managing a successful quality improvement process with multi-functional involvement (engineering, manufacturing, sales, etc.)
• Detailed knowledge / interpretation of EU regulations and FDA manufacturing experience are considered essential for this role
• Management experience in overseeing successful broad based electronics industry quality management systems in various industries including automotive, consumer electronics, military, aerospace, and telecommunications.
• 10 plus years’ experience in Quality/Compliance environment with at least 8 plus years demonstrated leadership in quality role driving best practices and developing high performing teams in a multi-site global manufacturing environment
• Experience in Medical Device manufacturing is required.
• Experienced with application of FDA and ISO quality standards in a government regulated healthcare industry. Experience with FDA (or Notified Body) inspections.
• Excellent written and oral communication skills; must have the ability to communicate effectively and project a professional image when giving and taking information in writing and in person.
• The ability to make effective and persuasive speeches and presentations on controversial or complex topics to management, employees, auditors and customers.
• Excellent analytical skills including the ability to consult with all internal departments.
• Strong technical and problem solving skills.
• Ability to create and effectively communicate regulations/standards.
• Ability to manage and execute on multiple, critical projects simultaneously.
• Strong ethics to escalate issues in the face of competing corporate priorities.
• Certified for Lead Auditor, Internal/External Audits

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