Quality Engineer II (Onsite)
Onsite, Sumter, Carolina, do, Sul
Job Description Summary
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.Job Description
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.
Essential / Key Job Responsibilities (including supervisory and/or fiscal):
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.
ADDITIONAL RESPONSIBILITIES
Operates within the Safety and QSR guidelines of BD-Sumter.
Performs other duties as assigned, such as Internal Audits, Complaint Investigations, etc. as assigned.
Education and Experience:
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).
ASQ CQE or Six Sigma Green Belt (preferred)
Work Environment:
BD is a smoke-free campus. Smoking and the use of electronic smoking devices, marijuana, or tobacco products are not allowed on BD property, grounds or in the parking areas. We appreciate your cooperation in adhering to this policy
False eyelashes, press-on fingernails, and Jewelry is not allowed on the production floor including dermals. Any associate wearing dermals will be required to cover them while working on the production floor.
Shoes are required to be Steel Toe and non-slip for all associates while on the production floor for safety purposes.
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.
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 health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
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.
Required Skills
Optional Skills
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Primary Work Location
USA SC - SumterAdditional Locations
Work Shift
US BD 1st Shift 8am-5pm (United States of America)As pessoas aqui são incríveis, e sua paixão pelo que fazem transparece em tudo o que fazem.
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