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Quality Engineer

Req ID: J2303218

  • Location
    Cayey, Puerto Rico, United States of America
  • Category Quality Group
  • Posted Thursday, May 12, 2022
  • Time Type Full time
  • Job Type Permanent Employee

Job Description

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
General:

  • 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.

Supplier Quality:

  • 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.

JOB QUALIFICATIONS
KNOWLEDGE REQUIREMENTS

  • 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

Accessibility Accommodation

If you are a qualified individual with a disability, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access https://careers.jabil.com/ site as a result of your disability. You can request a reasonable accommodation by sending an e-mail to Always_Accessible@Jabil.com with the nature of your request and contact information. Please do not direct any other general employment related questions to this e-mail. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to from this e-mail address.

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