Quality Engineer II (Onsite)

Becton Dickinson Medical Devices•Sumter, SC

2d•Onsite

About The Position

The Quality Engineer II performs a variety of compliance related duties associated with the medical devices manufactured at the BD site in Sumter, SC. This position is integral to the design and maintenance of quality systems to meet ISO and FDA guidelines, while working with a variety of local, US based and international resources at all levels of the company. The position will create and implement strategic quality plans and regulatory compliant operating procedures in support of routine validation as well as expansion and upgrade projects. Constant evolution to meet the ever-changing technological needs of the healthcare industry provides the quality engineer the opportunity for project ownership and quality system design in the transfer of new processes to the Sumter site. Reports directly to a Quality Manager of the assigned Business Team. 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.

Requirements

BA/BS degree (Major: Engineering, Sciences, Mathematics or other technical field) (preferred)
3 years work experience in Quality Assurance/Manufacturing. (required)
Validations, IQ, OQ, PQ and DOE tools. (required)
Statistical/investigative tools such as control limits, SPC, significance.(required)
Studies, P charts, probability studies, 8D, 5-Why etc. (required)
Effective written and verbal skills with the ability to accept responsibility and perform responsibilities with minimal supervision (required).

Nice To Haves

ASQ CQE or Six Sigma Green Belt (preferred)

Responsibilities

Serves as a resource to work group and project teams, within the plant and outside the plant relative to quality and regulatory issues.
Serves as a contributing, participating member of the assigned Business Team.
Maintains familiarity with the manufacturing processes and products to evaluate the cause and effect of defects and identifies trends in process and product quality.
Provides technical guidance for projects using the application of pFMEAs, risk mitigation, site validations, DOEs, and other experiments and investigations as assigned.
Conducts vendor (equipment and/or raw material) quality evaluations at vendor sites as required.
Ensures the contents of Validation protocols meets all applicable quality system requirements and product requirements.
Ensures the protocol is created in accordance with the plan.
Define the sampling points, sample sizes and process data to be collected.
Ensures the protocol was implemented in accordance with the plan and that the acceptance criteria were met.
Lead projects/project teams in the use of the continuous improvement tools, and methodologies such as Six Sigma, 8D, 5-Why, etc.
Works with assigned manufacturing department (s) to maintain the highest quality standards / requirements.
Track and trend quality metrics and assist in the identification of root causes, implementation of corrective/preventive actions and verification of effectiveness.
Initiates, reviews, and implements policies and procedures relating to product quality and process control as appropriate.
Ensures that all activities align with government (OSHA, FDA, ISO, etc.) regulations and corresponding policies/procedures including activities and programs as defined in Sumter’s Quality Manual.
Coordinates machine and process capability studies, analyzes data, and submits recommendations.
Coordinates communication between Unit Quality, Unit R&D and plant personnel on new products, product improvements and product issues.
Participates as a team member along with Engineering and Operations’ as required to achieve the overall objectives of the site.
Provides test and statistical support regarding customer complaint issues and makes recommendations on actions to be taken to address the issue.
Operates within the Safety and QSR guidelines of BD-Sumter.
Performs other duties as assigned, such as Internal Audits, Complaint Investigations, etc. as assigned.