Quality Engineer (Validation)

at  BD

JOB DESCRIPTION SUMMARY

Performs statistical analysis of new and existing processes through the use of design of multi-vari, factorial and performance experiments/testing; identifying root cause of product defects and process waste and recommending to management appropriate corrective action(s). Evaluates all changes, modifications and additions to product lines and determines the effect on product quality and costs. Coordinates the total Quality Awareness Program within his/her business segment, informing all inspection and management personnel of quality problems and solutions. Reports directly to a Quality Manager.

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.
BD is seeking a Sr. Quality Engineer to join the team at our medical device manufacturing site in Sumter, SC. As a Quality Engineer II, you’ll play an integral role in maintaining compliance with ISO and FDA guidelines while collaborating with local, US-based and international resources. You’ll be responsible for building and implementing strategic quality plans and regulatory compliant operating procedures that support routine validation, as well as expansion and upgrade projects. If you’re passionate about quality and are looking for a challenging and rewarding career, we want to hear from you!

EDUCATION AND EXPERIENCE:

• BA/BS Degree in Engineering, Sciences, Mathematics, or equivalent (required).
• Major in Mechanical/Industrial Engineering preferred.
• 1- 3 years work experience in Quality Assurance/Manufacturing

KNOWLEDGE, SKILLS, AND ABILITIES

• Solid understanding of statistical/investigative tools, Process Validation and Change control, etc. (Required)
• Effective written and verbal skills with the ability to accept responsibility and perform responsibilities with minimal direction. (Required)
• Previous experience in implementing, and strong knowledge of, Process Validation (IQ, OQ, PQ, Software) and Change Control (Required).
• Solid understanding of QSRs / ISO13485:2016 (Preferred)

• Through the use of accepted statistical engineering principles and experimentation design, initiates capability studies of processes to identify causes of chronic levels of defects and remedy those areas associated with a high cost of quality.
• Provides functional support to the Engineering Department for the writing of protocols, data gathering and data analysis associated with the Plant Validation Program – including prospective, retrospective and revalidation efforts. Conduct process capability studies and/or process optimization studies prior to validations.
• Acquires data from critical processes allowing for trend analysis and recommends action to be taken to maintain/obtain statistical process control.
• To assure coordination of the overall quality effort within the plant in the following areas:
• Provides plant self-audit information on the product and process to assure compliance with all government regulations (QSR, FDA and Contractual).
• Periodically reviews Quality specifications to assure accuracy and adequacy.
• Formulates and implements policies and procedure relating to product quality or process control as appropriate.
• Provide test and statistical support to customer complaint issues that arise and make recommendations on actions to be taken.
• Conducts vendor (equipment and/or raw material) quality evaluations at vendor sites as required.
• This position will focus to support and maintain the validation process that are strategic for the site and require horizontal deployment.
• Other duties as assigned to support operational performance goals.