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

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.

  • 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

  • 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

Industry Standard/Category: Sr. QAE

ID: 2018-11372

Career Level: experienced

Division Name: BOC Juarez

Relocation: NO

External Company Name: C.R. Bard, Inc.

External Company URL: www.crbard.com

Street: Gral. Robrto Fierro 6408

C. R. Bard, Inc. (NYSE: BCR) is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 13,000 people around the world. Founded in 1907, we pioneered many devices that are now the cornerstones of modern healthcare.

We expect the highest levels of quality, integrity, service, and innovation from our employees – on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded. Bard is a M/F, Disabled and Vet EEO/AA Employer.

Be Your Best at Bard – and ultimately, you can have an impact on the lives of people around the world.