SUMMARY
Represent the quality function of technical support, in conjunction with other internal support groups, regarding issues affecting manufacturing.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
· Develop and maintain QA plans and process routings, which reflect intended/actual activities.
· Provide support for all quoting activities by participation in initial process design, development, and implementation phases.
· Evaluate and support inspection processes via inspection aids and instruction guidelines.
· Support all training programs by development and implementation of specialized training sessions for all applicable functions.
· Conduct periodic review and maintenance of all documentation files; develop appropriate systems for document storage and access.
· Review all supplier or customer discrepancies. Coordinate and track the corrective/preventative action effort.
· Provide trend analysis of defects occurring at the customer, supplier and internally.
· Participate in the vendor survey activities as applicable.
· Drive proactive participation with suppliers and (when possible) aid in their process improvement efforts.
· Interface with all departments as applied to the Policies and Procedures with special regard to ISO, EN4600 and GMP documentation.
· Monitor departmental activities and provide technical and logistical guidance/support for the quality engineering staff as applicable.
· Interface and provide technical support on quality issues with the customer as needed.
· Support and focus corrective action efforts and utilizing the SPC data and corrective action tracking package and create and implement any meetings, procedures, or team-building concepts as necessary as part of the corrective/preventative effort.
· Serve as liaison between Jabil Circuit and suppliers or customers on quality related issues.
· Improve technical support for the quality organization.
· Adhere to all safety and health rules and regulations associated with this position and as directed by supervisor.
· Comply and follow all procedures within the company security policy.
MINIMUM REQUIREMENTS
Bachelor's degree required and two years related experience; or equivalent combination of education and experience.
Knowledge of manufacturing and medical industry is preferred.
Experience in PQE, SQE and Operation Quality
ISO 13485 : 2016, Validation, IQ,-OQ,-PQ, FDA knowledge will be advantage.
