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
Process Validations (IQ, OQ, PQ)
Mandatory compliance to general and safety procedures applying to this position
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
Career Level: experienced
Division Name: BOC Juarez
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.