Direct the design, development and maintenance of quality systems and protocols for processing materials into partially finished or finished products for a business unit or corporate organization. Direct the audits of quality systems for deficiency identification and correction as applied to new and existing company products. Direct the development of inspection and testing processes, as appropriate. Reports to Senior Management on the overall effectiveness of the Quality System.
ESSENTIAL DUTIES AND RESPONSIBILITIES
· Provides early guidance to support the policies and process with the quality department members to promote the understanding and compliance.
· Establishes the short and long-term goals of the area.
· Direct activities to facilitate the interaction between Quality and the other functional operations area.
· Provides early guidance and solution’s concerning quality evaluation, control systems and protocols, e.g., non-compliant situations, customer scalations, requirements, government regulations, accuracy of products.
· Executes all management reports to clients, business unit.
· Collaborates with customer’s in order of accomplish their requirement’s or for any scalation.
· Development and modification of all quality evaluation and control systems in areas of product responsibility, and in compliance with company policies, customer requirements and government regulations.
· Direct the development of methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
· Provides early guidance to statistical analysis projects to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
· Directs the auditing process of quality systems for deficiency identification and correction, and delegates to the subordinates the implementation of the corrective action plans 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
· Directs the development of sustainable, repeatable and quantifiable business process improvements. Develops and modifies as necessary and required on the status of quality assurance programs and practices.
· Provide direction and training, as necessary, to a staff of Managers and/or Quality Assurance Engineers.
· Provides early guidance concerning compliance all site required agency certifications related to product and process quality. ISO 9001, ISO 13485, QS9000, ISO 14000 and TS16949
· Establishes 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.
· Reviews and approves 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.
· May perform other duties and responsibilities as assigned.
· Ability to direct and manage a Department or Team of employees.
· Excellent verbal and written communication skills.
· Multi-task management.
· Responsible for building strong department skill sets within direct reports.
· History of success in making change and achieving objectives.
· Successful track record working in a matrix/collaborative environment.
· Teamwork and collaboration.
· Strong interpersonal skills.
EDUCATION & MINIMUM EXPERIENCE REQUIREMENTS
· Bachelor’s degree required. Master’s degree preferred in Engineering or Technology disciplines.
· 8 years of experience (or equivalent) and required industry experience.
· Or a combination of education, experience and/or training.
· Extensive background and experience in Quality management systems in healthcare/FDA regulated industry.
· Proven track record as a quality partner in a manufacturing plant.
· Medical device experience highly desired.
· Success stories of coaching and developing Quality professionals and teams
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