Quality Engineer II

Becton Dickinson; South Carolina; On-site; USD 70,000 - 95,000; Full time

Job summary

Becton Dickinson in Sumter, USA, is seeking a Quality Engineer focused on statistical analysis and CAPA investigations to improve product quality and reduce costs. The role involves data-driven decision making, process validation support, and rigorous adherence to QSR/FDA regulations.

Responsibilities include leading root-cause analysis, coordinating CAPA actions, and ensuring ongoing quality improvements across manufacturing processes.

Qualifications

• BA/BS Degree in 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)

Responsibilities

• Initiates capability studies of processes to identify causes of chronic defects and remedy high-cost areas.
• Support plant validation programs with data gathering and analysis; conduct capability/optimization studies pre- and post-validation.
• Lead investigations to identify root causes of defects and process waste; assist CAPA action plans and implementations.
• Acquire data from critical processes for trend analysis and report quality status at daily management meetings.
• Coordinate plant-wide quality efforts, conduct self-audits, and ensure compliance with QSR, FDA, and contractual requirements.

Skills

Statistical analysis

Root cause analysis

CAPA investigations

Quality tools

Education

BA/BS in Engineering/Sciences/Math

MS in Engineering/Sciences (preferred)

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. Coordinating 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

1. 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 RESPONSIBILITIES

1. 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)

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.

To learn more about BD visit https://bd.com/careers .

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.

Primary Work Location

USA SC - Sumter

Work Shift

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