Job Description Summary
Supplier QA Engineer will be responsible for providing leadership and guidance to the supplier to ensure compliance to established corporate standards and to regulated agencies for industry (ISO, FDA and others as applicable). Responsible for the execution, planning, development and/or implementation of quality systems that support the organization in the successful management of suppliers.
Job Description
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Our people make all the difference in our success.
Performs any combination of tasks involved in the manufacture and assembly of medical devices. We are the makers of possible.
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us.
- Provide a timely follow up and communication on all supplier related quality issues (NCs / SCARs) reported in production / incoming areas, following applicable procedures.
- Provide proper analysis, follow up and communication all supplier related customer complaints, following applicable procedures.
- Asure the completion of Supplier Audits and/or Supplier Surveys/Assessments, following Supplier Annual Monitoring Plan and applicable procedures.
- Participate during supplier selection-qualification and approval to provide required quality-related input/output, following applicable procedures.
- Provide support and/or actively participate in internal and/or external audits (FDA, ISO, Corporate).
- Work with project teams to coordinate or implement supplier quality initiatives in the plant.
- Provide guidance on documentation associated with supplier qualification/approval and supplier-driven changes including supplier validations, supplier quality agreements, process controls, audits, and compliance to regulations and company procedures.
- Work with suppliers to improve processes and Quality Systems.
- Strong understanding of Root Cause Analysis, Corrective Action, Preventive Action, Efficiency Verification.
- Strong Microsoft Office skills (Word and Excel).
- Strong working knowledge of statistical quality tools and statistical process control (SPC).
- Process Validation Activities skills (IQ/OQ/PQ), preferred.
- Strong working knowledge of Quality System Regulations, ISO regulations (ISO13485 preferable), Risk Management, GMPs / GDPs.
- Preferred Knowledge on Foreign country (Japan, Brazil, Canadian, China, Europe) Medical Device regulations.
- Demonstrate effective communication, presentation and influencing skills, fluidly bilingual English and Spanish required.
- Bachelor's degree in engineering or equivalent.
- 2 years of experience on industry; quality experience on medical devices preferred.
Required Skills
Optional Skills
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Primary Work Location
MEX Reynosa
Additional Locations
Work Shift