Senior Quality Engineer

About the role

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.

Responsibilities

• 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 guidance to the Engineering Department for the development of protocols, data gathering and data analysis associated with the Plant Validation Program – including prospective, retrospective and revalidation efforts.
• Conducts process capability studies and/or process optimization studies prior to validations.
• Leads investigations to identify root cause of product defects and process waste and recommends appropriate corrective action(s) to management.
• Supports CAPA investigations, action plan development and implementation activities.
• Acquires data from critical processes allowing for trend analysis and recommends action to maintain/obtain statistical process control.
• Trends data from QNs/defects, blocked stock and other quality KPIs to report on the daily state of quality within the operation. Information is presented at the daily T2 management meeting.
• Assures coordination of the overall quality effort within the plant by:
  • Providing plant self-audit (weekly Gemba) information on the product and process to assure compliance with all government regulations (QSR, FDA and Contractual).
  • Periodically reviewing Quality specifications to assure accuracy and adequacy.
  • Formulating and implementing policies and procedures relating to product quality or process control as appropriate.
  • Providing test and statistical support to customer complaint issues that arise and making recommendations on actions to be taken.
  • Conducting vendor (equipment and/or raw material) quality evaluations at vendor sites as required.
• Operates within the Safety and QSR guidelines of BD-Sumter.
• Performs miscellaneous duties as required by management.

Requirements

• BA/BS Degree (Major: Engineering, Sciences, Mathematics, or equivalent) (Required).
• Minimum of BA/BS Degree AND 3 years' work experience in Quality Assurance/Manufacturing OR MSc. Degree AND 2 years' work experience (Required).
• Proven understanding of statistical/investigative tools such as control limits, SPC, significance 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 direction. (Required).
• Working knowledge of Validations, IQ, OQ, PQ, and DOEs (Required).
• Proven understanding of ISO13485:2016 (Preferred).
• Six Sigma training (Preferred).

Benefits

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.

Schedule

US BD 1st Shift 8am-5pm (United States of America)

Location

USA SC - Sumter