Descripción del Trabajo
Represent the quality and validation functions of technical support, in conjunction with other internal support groups, regarding issues affecting metals additive manufacturing (3D Printing) of products on global customer accounts.
Lead equipment and product qualification and validation activities of metal additive manufacturing (3D Printing) equipment and products. Serve as liaison between Jabil Inc. and suppliers or customers on quality related issues during pre-production qualification and validation activities (e.g., equipment, material and process qualifications) and production of metal additive manufacturing (3D Printing) parts for the medical device industry.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
- Develops and maintains master validation plans and equipment and product qualification protocols (IQ/OQ/PQ/PPQ), QA plans and timeliness of global new product introductions utilizing Advanced Product Quality Planning and Process Optimization specific to the customer.
- Maintains manufacturing procedures, work instructions, design and production guides, etc.
- Translate customer requirements and specifications into robust quality processes and procedures for production.
- Create qualification and validation testing schedules, perform tests and report test results to ensure that they meet customer specification requirements.
- Assists in driving the standardization of manufacturing processes of global customer accounts.
- Creates inspection and test plans of incoming materials and goods, in-process materials, and final products in accordance with internal and external customer requirements.
- Evaluates and provides input to inspection processes via inspection aids and instruction guidelines. Prepares and maintains inspection and testing documents. Study the effectiveness of inspection activities.
- Evaluates and recommend inspection gauges and test equipment. Investigate causes of sporadic defects.
- Maintains records and documents in support of qualification activities (IQ/OQ/PQ/PPQ) and validation plans, e.g., manufacturing procedures, work instructions, design and production guides, etc.
- Develops tools for quality improvement such as flow charts, check sheets, pareto reports, histograms, cause-and-effect charts, scatter diagrams and controls charts. Implement process control systems.
- Provides insight and active assistance in implementing and maintaining process Improvement and optimization concentrating on proactive methodologies.
- Leads in performing FMEAs for processes and products under development and/or qualification.
- Provides support to process engineering in any quality issues with tooling, machines or processes.
- Provides support for all quoting activities by participation in initial process design, development, and implementation phases.
- Reviews all supplier, internal, and customer discrepancies, coordinate and track the effectiveness of corrective/preventive action (CAPA) efforts.
- May perform other duties and responsibilities as assigned.
- Conducts periodic review and maintenance of all documentation files; develops appropriate systems for document storage and access.
- Participates in the vendor survey activities as applicable. Drives proactive participation with suppliers and (when possible) aids in their process improvement efforts.
- Supports all global training programs specific to their customer by development and implementation of specialized training sessions for all applicable functions.
- Interface with all departments as applied to the Policies and Procedures.
- Provide insight and assistance of implementing and maintaining Process Improvement and Optimization.
- Interface and provide technical support on quality issues with the customer as needed.
- Coordinate Customer Complaint investigations on items returned to the facility for analysis.
- 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.
- Bachelor’s Degree in Engineering or applied science.
- Minimum of 5 years of experience in quality control in the medical product industry preferred. 7 years preferred.
- 3-5 years of experience with medical qualification and validation protocols for equipment, processes and product.
- 1-3 years of experience with cleaning processes for medical devices.
- Ability to effectively present information and respond to questions from groups or managers, clients, customer and the general public.
- Excellent written and oral skills and the ability to organize and follow up on multiple priorities.
- Able to work in a self-paced environment and provide leadership to team as appropriate
- Ability to effectively collaborate with multi-disciplinary teams.
- Knowledge of metallic materials for powder bed fusion (3d printing) equipment/processes used to fabricate parts for medical industry preferred.
- Experience in Additive Manufacturing of metals preferred.
- Demonstrated ability manage projects. Experience with project management software preferred.
- Experience in supplier quality preferred.
- Or equivalent combination of education and experience.
- Travel up to 40%