Job Description Summary

Job Description

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 collaborating with several local, US based and international resources at all levels of the company. The position will build and execute strategic quality plans and regulatory compliant operating procedures supporting routine validation as well as expansion and upgrade projects. Constant evolution to meet the ever advancing technological needs of the healthcare industry provides this position 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.

ESSENTIAL FUNCTIONS

This position will serve as a resource to work group and project teams, within the plant and outside the plant relative to quality and regulatory issues. They will maintain familiarity with the manufacturing processes and products to evaluate the cause and effect of defects and identify trends in process and product quality. They will also provide technical guidance for projects by using pFMEAs, risk mitigation, site validations, DOEs, and other experiments and investigations as assigned, as well as conduct vendor (equipment and/or raw material) quality evaluations at vendor sites as needed.

This role will ensure the contents of Validation protocols meet all applicable quality system and product requirements. This includes monitoring that the protocol is crafted in accordance with the plan and defining the sampling points, sample sizes and process data to be collected. They will need to make sure the protocol was executed accordingly and that the acceptance criteria were met.

Other functions include:

• Lead projects using the application of 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 efficiency.
• 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.
• May lead MWO / PIC initiation, implementation and follow through in support of initiatives. This may include working with Unit and Site associates to ensure the MWO is approved as required, ensuring all associates participating in the MWO are trained to execute the MWO, ensuring that all MWO requirements are met (required testing is completed, supporting paperwork is collected and reviewed for accuracy and completeness) and supporting documentation / product is forwarded to the requestor.

Education and qualifications:

Basic:

• Education: BA/BS Degree (Major: Engineering, Sciences, Mathematics or equivalent).
• 3+ years' experience in Quality Assurance/Manufacturing.
• Operates within the Safety and QSR guidelines of BD-Sumter.
• Other duties as assigned, such as Internal Audits, Complaint Investigations, etc.
• Working knowledge of Validations, IQ, OQ, PQ and DOEs
• Solid understanding of statistical/investigative tools such as control limits, SPC, significance studies, P charts, and probability studies, 8D, 5-Why etc.
• Effective written and verbal skills with the ability to accept responsibility and perform responsibilities with minimal direction.
• Regularly required to take a leading role, including assigning activities to other associates who perform work that is similar or closely related to this position
• Digital literacy: SAP, MS Outlook, MS Word, Minitab, MS PowerPoint, MS Excel

Preferred:

• Certification (ASQ CQE, Six Sigma) preferred
• Solid understanding of QSRs / ISO13485:2016 is desirable

“Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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.”

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