General Summary or Responsibilities:
- Responsible for the development of inspection methods, Quality instructions, and inspection sampling plans to customer and Jabil’s specifications.
- Works in coordination with the Program Managers, Quality Leadership and Technicians to assure product compliance to customer specifications and regulatory requirements.
- Implements/coordinates implementation of product and process changes managed according to change procedure.
- Responsible for investigating and recommending solutions to quality problems.
- Provide leadership and initiative to QS organization through continuous improvement projects.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Evaluate and/or design sampling plans and process control plans for lot acceptance and control processes.
- Study the effectiveness of inspection activities.
- Design means for measuring accuracy and documenting of inspection work.
- Evaluate and recommend inspection gauges and test equipment. Investigate causes of sporadic defects.
- Provide consultation services to Quality Systems and Manufacturing departments.
- Implement process control systems.
- Provide technical support for process, component, product, gauges, equipment, software, validations as required.
- Provide technical support for new product transfer, developing systems for new processes as required.
- Establish and maintain appropriate documentation as required for Quality Systems activities.
- Investigate identified quality problems to determine root cause and corrective actions needed. (Non-Conforming Material Reports-NCMR's, Customer Complaints, Supplier Corrective Actions Reports, CAPA’s).
- Maintains and reports on trend information on internal/external failures and issues recommendations for corrective actions, as necessary
- Support manufacturing in analyzing manufacturing product lines to determine how or where within the manufacturing or inspection process, the root cause of non-conformances or customer complaints exist.
- Execute Statistical Analysis that includes, but not limited to: ANOVA, DOE, Weibull, GR&R, Capability, FMEAKT and SPC as required.
- Other responsibilities may be assigned and not all responsibilities listed may be assigned.
- Provides technical support on Supplier Quality Management
- Provides regular updates to Quality and Work Cell Leadership on the execution of the strategy.
- Provides support for NPI activities by participation in the Raw Material Incoming Inspection process as required.
- Ensures that all production supplier issues are resolved in a timely manner, and corrective actions are implemented.
- Defines and develops the appropriate Inspection Plans and Inspection Methods via inspection aids and instruction guidelines and trains the Receiving Inspection Auditors.
- Responsible for the ongoing site suppliers’ evaluation by using site information collected from Receiving and Incoming areas.
- Maintains the Incoming Inspection database and by liaison efforts with customer work cells. Performance will be reported internally, to the supplier, and to the Work Cell where applicable.
- Reviews all supplier discrepancies. Coordinates and tracks the corrective/preventative action effort.
- Leads SCAR – Supplier Corrective/Preventive Action and Raw Materials’s Non-Conforming Reports, process for problem resolution and continuous improvement, including critical analysis of supplier DOE (Design of Experiment), CPK (Process Capability Index), Gauge R&R (Repeatability and Reproducibility) studies.
- Proactively communicate information or issues that may impact the product costs or manufacturability to all affected departments.
- Adhere to all safety and health rules and regulations associated with this position and as directed by supervisor.
- Acts as a Subject Matter Expert (SME) for Incoming Quality operation activities, assuring the correct execution of quality tests for raw material release.
- Excellent technical written and oral skills and the ability to organize and follow up on multiple priorities.
- Able to make solid decisions that will effectively support the business and company policies.
- Strong Root Cause Analysis expertise
- Able to work in a self-paced environment
- Team player.
- Project Management
- Geometrical Dimension and Tolerancing
- Statistical Techniques Applications for Analysis
- Able to understand application of regulatory requirements to the business.
- Able to analyze and develop quality methods. Responsible for writing clear and concise protocols, study reports, and procedures.
- This position requires consistent involvement with and knowledge of changes in medical devices associated regulations and standards.
- Aptitude to respond to shifting priorities through appropriate realignment of required tasks.
- Skilled in use of PC based systems including, but not limited to statistical analysis, word processing, inventory management, quality system, non-conforming product systems and data base management
- PCBA Handling and Sterilization Process knowledge desired
EDUCATION AND EXPERIENCE
- Bachelor’s Degree in Industrial Engineering or related engineering field preferred
- Fully bilingual (oral and written) required
- Minimum of three years of experience on automated or semi-automated medical assemblies medical, medical devices process validations, and new product introduction.
- Lean Six Sigma knowledge
- Expertise and knowledge working with IPC A-610 standard, certification preferred
- Certified or Licensed Engineer by CIAPR
- Certified as Quality Engineer by ASQ preferred
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