BD (Becton, Dickinson and Company) Sr. QAE in Ciudad Juárez, Mexico

Category: Sr. QAE

Job ID: 2018-11372

Career Level: experienced

Division: BOC Juarez

Relocation: NO

Location: Juarez,Chihuahua,Mexico

Overview:

To develop and document Quality plans and procedures as required. Prevent and resolve Quality problems. Improve areas of high quality costs. To assist suppliers in meeting Juarez Quality needs. Represent quality interests and concerns on project teams. Conduct root cause analysis and investigation for customer complaints and non conformance product. Ensure compliance with Corporate, ISO, FDA and Local standards requirements.

Essential job Functions:

  • Provides direct technical guidance to QC engineers or QC technicians

  • Plan and develop the quality control program

  • Perform validation studies on new products, processes or equipment

  • Provide technical support to resolve quality problems in development, pilot, manufacturing

  • Design and conduct quality engineering studies to determine causes of quality non-conformances, initiate changes in process, tooling,etc., to correct them

  • Make dispositions of rejected non-conforming products’ conduct MRB action when required. Assure segregation and identification of rejected material and implementation of disposition by production personnel

  • Organize and generate detailed quality information reports to engineering, manufacturing and management

  • Provide documented instructions for performance of QC inspections, including QC plans, inspection and test procedures, and quality Standards

  • Plan and coordinate quality activities which involve production, engineering, etc

  • Conduct other quality control projects as assigned by the manager of assurance

  • Exercise control over the quality of conformance of the products generated in his area\Design and qualify inspection and test equipment

  • Component Qualifications

  • Process Validations (IQ, OQ, PQ)

  • Mandatory compliance to general and safety procedures applying to this position

  • Software Validations

  • Customer complaint evaluations

  • Develop and reviews PFMEAs

Basic Qualifications:

  • Bachelor degree in technical sciences

  • Minimum 3 years experience in Quality Assurance with background as QA Engineer and Supervision

  • Medical Device Background

  • Ability to communicate in English (oral and written)

  • Knowledge on International Regulations and Standards (i.e. ISO-13485, FDA, etc)

  • Certified Quality Engineer (Preferable)

  • Knowledge on basic Quality Tools and statistical techniques. (Control charts, sampling plans, Design of experiments, etc)

  • Knowledge on Quality systems

  • Experience in Supervision and leading teams.

  • Root cause analysis background

  • Able to work under pressure

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status