Site Quality Assurance Manager

Role Overview

• Provides input to and support of plant and company safety initiatives.
• Manages the development, modification and maintenance of all quality evaluation and control systems in areas of product responsibility, and in compliance with company policies, customer requirements and government regulations.
• Manages and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
• Manages statistical analysis projects to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
• Manages the auditing process of quality systems for deficiency identification and correction, and ensures that corrective action plans are put into place and executed in a timely manner.
• Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with all, customer and regulatory requirements.
• Manages the development of sustainable, repeatable and quantifiable business process improvements. Reports to management as necessary and required on the status of quality assurance programs and practices.
• Manages compliance
• all site required agency certifications related to product and process quality. ISO 9001, ISO 13485, QS9000, ISO 14000 and TS16949.
• Manages up front quality planning for new products to ensure appropriate quality systems and processes required to support the introduction are developed and implemented.
• Exchange knowledge and information with other Jabil facilities to ensure best practices are shared throughout the Jabil organization.
• Generate and maintain applicable quality system documentation, as needed. Documents such as Device Master Record (DMR), Design History File (DHF), validation protocols, for example, and other specified documents in support of customer projects.
• Ensure conformity of initial and ongoing validations performed in support of the GMP quality systems.
• Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/position.

Requirements

• Bachelor’s degree required. Master’s degree preferred. Preferred Engineering or Technology disciplines.
• Minimum ten (10) years of experience and required Healthcare industry experience. Or a combination of education, experience and/or training.
• Proficiency in use of personal computers, Microsoft Office products (Excel, Word and PowerPoint) and e-mail skills required.

Benefits

• Competitive base salary
• Medical, Dental, Prescription Drug, and Vision Insurance with HRA and HSA options
• 401K match
• Employee Stock Purchase Plan
• Paid Time Off
• Tuition Reimbursement
• Life, AD&D, and Disability Insurance
• Commuter Benefits
• Employee Assistance Program
• Pet Insurance
• Adoption Assistance
• Annual Merit Increases
• Community Volunteer Opportunity