QA Supervisor

Becton Dickinson Medical Devices•El Paso, TX

1d•Onsite

About The Position

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. JOB OVERVIEW This position assists in the establishment, implementation, and maintenance of programs crafted to assure control of processes and products within established standards of quality. The position uses problem solving and root cause analysis to address quality concerns and improve quality and/or efficiency of products/lines under their responsibility. This role also supports product and risk management of new product development, product launches and sustaining activities.

Requirements

Bachelor’s degree in engineering, and minimum of four (4) years’ experience in engineering or Quality engineering experience within the medical device or pharmaceutical industry.

Nice To Haves

Quality Engineering Certification ( ASQ) or equivalent
Ability to apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc.).
Application of statistical techniques and risk assessment techniques.
Solid understanding of test method (development and validation), equipment qualifications,
Experienced in the medical device or pharmaceutical industry,
Practice in the use of root cause analysis tools

Responsibilities

Review and Approve nonconformance investigations.
Participate in CAPA investigations.
Support the implementation of new products and ongoing production of existing products, processes, and changes by developing and maintaining quality plans, approval of validation plans and protocols, inspection methods, and work instructions.
Responsible for the investigation, documentation, root cause, and identification of corrective action activities of customer complaints.
Compile, analyze and interpret inspection, process, and product data to identify and prevent quality problems and identify continuous improvement opportunities.
Responsible for generating rework instructions and performing or assisting with rework training.
Conduct training regarding Product and Quality Requirements.
Monitor nonconformances including aging, financial impact and is a member of the cross-functional investigation and corrective action team to resolve nonconformances.
Support manufacturing and quality process continuous improvement projects.
Facilitate appropriate and compliant use of change control and risk management processes.
Communicate across functions/departments.
Develop working knowledge of applicable regulatory, Corporate and/or Business Unit requirements.
Lead implementation of the Quality Component of the BD Excellence operating system.
Assists in regulatory and customer audits as needed.
May conduct internal and/or supplier audits.
Understand and comply with applicable regulator requirements, local and global BD quality policies, procedures, and practices through consistent application of sound quality assurance principles.
Comply with all local, state, federal, and BD Safety regulations, policies, and procedures including RCRA Hazardous waste regulations.
Possibly supervise Quality Technicians.
Other duties as assigned.