Job DescriptionPerforms 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.
ESSENTIAL FUNCTIONS1. 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.
2. 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. Conduct process capability studies and/or process optimization studies prior to validations.
3. Leads investigations to identify root cause of product defects and process waste and recommending to management appropriate corrective action(s). Supports CAPA investigations, action plan development and implementation activities.
4. Acquires data from critical processes allowing for trend analysis and recommends action to be taken 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.
5. To assure coordination of the overall quality effort within the plant in the following areas:
- Provides plant self-audit (weekly Gemba) 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.
ADDITIONAL RESPONSIBILITIES1. Operates within the Safety and QSR guidelines of BD-Sumter.
2. Performs miscellaneous duties as required by management.
QUALIFICATIONS:- 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)
Primary Work LocationUSA SC - Sumter
Additional LocationsWork ShiftUS BD 1st Shift 8am-5pm (United States of America)
