Senior Quality Engineer

BD; Sumter (SC); On-site; USD 80,000 - 110,000; Full time

Job summary

BD is seeking a Quality Engineer to perform statistical analysis of processes, identify root causes of defects, and guide CAPA actions in the Sumter facility. The role requires a BA/BS (Engineering/Sciences/Math) with 3 years QA/manufacturing experience or MSc with 2 years, plus strong knowledge of statistical tools.

The ideal candidate will support validations (IQ/OQ/PQ), implement process controls, and ensure compliance with ISO13485:2016.

Qualifications

• BA/BS degree in Engineering, Sciences, Mathematics or equivalent required.
• Minimum of BA/BS degree and 3 years in Quality Assurance/Manufacturing or MSc and 2 years required.
• Strong understanding of statistical/investigative tools (control charts, SPC, 8D, 5-Why).
• Effective written and verbal skills with ability to work with minimal direction.
• Knowledge of Validations (IQ/OQ/PQ) and DOEs required.

Responsibilities

• Initiate capability studies to identify causes of defects and cost issues.
• Guide data gathering and analysis for plant validation programs.
• Lead investigations to identify root causes and implement corrective actions (CAPA).
• Collect and trend data from quality KPIs and report to management.
• Ensure plant-wide quality alignment and compliance with regulations.

Skills

Statistical methods

Quality assurance

Root cause analysis

Education

BA/BS in Engineering/Sciences/Mathematics

MSc in Engineering/Sciences/Mathematics

Tools

Control charts

SPC

8D

5-Why

DOEs

Job description

We Are The People Who Give Possibilities Purpose

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.

Job Description

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.

Essential Functions

• 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. Conduct process capability studies and/or process optimization studies prior to validations.
• 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.
• 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.
• 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 Responsibilities

• Operates within the Safety and QSR guidelines of BD-Sumter.
• 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)

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. 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.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

Required Skills

Optional Skills

Primary Work Location

USA SC - Sumter

Additional Locations

Work Shift

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