Supplier Quality Engineer

Regulatory Jobs; El Paso (TX); On-site; USD 90,000 - 125,000; Full time

Job summary

BD, a leading global medical technology company, seeks a Supplier Quality professional at our USA TX site to drive supplier quality programs and audits. You will work with procurement, R&D, engineering, and operations to resolve supplier-related issues and implement effective CAPA actions.

The role requires deep knowledge of GMP, ISO 13485, ISO 14971, and strong documentation skills. Fluency in Spanish and English is preferred for global supplier interactions.

Qualifications

• Bachelor’s degree in Engineering or related field.
• 5 years Supplier Quality/Development experience.
• Understanding of 21 CFR 820, ISO 13485, ISO 14971.
• Experience in a GMP-regulated environment (medical device/pharma).
• Experience with plant/supplier audits (GMP).
• Documentation and technical writing in regulated environments.
• Bilingual Spanish/English.
• FDA inspection experience.

Responsibilities

• Collaborate with suppliers and partners to ensure robust materials, products, processes, and systems.
• Lead root cause investigations and CAPA, driving corrective actions with suppliers.
• Manage supplier issues; plan, execute, and report supplier quality system audits.
• Partner across Procurement, R&D, Engineering, Quality, Operations to resolve supplier-related issues.
• Monitor supplier performance metrics and drive risk mitigation and issue resolution.
• Implement supplier change management including notifications and impact assessments.
• Own supplier quality projects with limited supervision and leadership.
• Apply PM/QA methodologies to SQM projects and continuous improvement initiatives.
• Analyze quality data to identify trends and drive resolution with global teams.
• Collaborate on process/product improvement with operations and franchise teams.
• Prepare Supplier Quality Agreements and engage with supplier quality managers.
• Develop/execute Quality Risk Management for supplier-related matters.

Skills

Supplier Quality

Root Cause Analysis

GMP Awareness

Bilingual Spanish/English

Education

Bachelor's degree in Engineering or related field

Job description

We are the people who give possibilities purpose

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.

Job Description

Job Responsibilities

• Collaborate with suppliers and business partners to ensure robust materials, products, processes, and systems.

• Support internal and supplier root cause investigations and CAPA. Drive corrective actions for supplier process by driving suppliers to true root cause analysis and corrective and Preventive actions

• Manage and escape supplier issues when intervention or a change at a supplier is necessary.
  Plan, execute, report and follow-up on supplier quality system audits

• Partner with Procurement, R&D,Engineering/Technical Operations, Quality, Operations, and Suppliers in the timely investigation,resolution/prevention of supplier-related issues to minimize/prevent business disruptions.

• Monitor and analyze supplier performance metrics, identify areas of opportunity, communicate supplier risks, and drive the resolution of supplier quality issues and risk control processes.

• Implement supplier change management process including change notification, dissemination of information, impact assessment, approval of changes, and supports material/supplier qualifications.

• Own, drive, and lead the assigned Supplier Quality related projects, activities, initiatives with limited supervision.

• Utilize Project Management methodologies to plan, organize, connect, shape, lead, and deliver results for SQM projects.

• Utilize analytical and problem-solving skills to develop and optimize supplier performance working in conjunction with the Worldwide Supplier Quality Management Team.

• Analyze quality data and identify trends impacting risk benefits requirements of product and quality systems for external suppliers. Lead discussions to drive resolution.

• Collaborate with operations and franchise operations development on process/product improvement projects.

• Prepare Supplier Quality Agreements and drives discussion with supplier while consulting Supplier Quality Manager.

• Develop/execute Quality Risk Management process for supplier-related matters with partnerships of subject-matter experts

• Lead component qualification change projects in collaboration with key business partners and the supplier’s applicable functional groups.

• Apply appropriate Quality Engineering and PEx tools (e.g. PM/VSM, Kaizen, DMAIC, FMEA/FTA, RCA, MSA, SPC, Cp/Cpk/Cpm/Ppk, Hypothesis Testing, ANOVA/DOE/EVOP, etc.) to support innovations and continuous improvements

• Comply with all applicable quality management system, environmental, safety and occupational health policies. (for example, ISO 13485, ISO14001 & OSHAS18001).

• Responsible for communicating business related issues or opportunities to next management level

• Other duties as assigned

Required Qualifications

• Bachelor’s degree in Engineering or a related field

• 5years Supplier Quality and/or Supplier Development

• Understanding of 21 CFR 820, ISO 13485, and ISO 14971 requirements

• Prior Supplier Quality experience in a manufacturing plant or technical background

• Working experience in good manufacturing practice regulated environment is preferred (medical device, pharmaceutical, etc.)

• Demonstrated knowledge of manufacturing principles and practices, and procedures

• Direct experience in plant and/or supplier GMP auditing

• Broad experience with quality systems, including but not limited to validation, non-conformance, CAPA/SCAR systems andinvestigations,production and process controls

• Experience with documentation and technical writing skills, in a regulated compliance environment

• Demonstrated ability to identify compliance risks and assess business impact

• Ability to manage complexity and lead critical discussions

• Ability to deal with complex issues using deductive reasoning, critical analysis skills and systematic approaches

• Bilingual Spanish English

• Prior experience with FDA inspection

Preferred

• Advanced Degree

• Certified Lead Auditor is a plus (ISO 13485)

• New product introduction experience

• Broad knowledge of QS Regulations and Supplier Management principles

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visit https://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally protected characteristics.

Required Skills

Optional Skills

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Primary Work Location

USA TX - El Paso - Northwestern Dr.

Additional Locations

Work Shift