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BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics, and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues. 

Position   Description    
JOB SUMMARY (Briefly describe the job’s primary purpose or contribution to the department or organization)

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 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.

Responsible for product and service quality evaluation and control:

• Works multi-functionally in the development and or maintenance of products and or services.

• Supports equipment and process-related issues; activities including equipment, process, materials, and method validation as well as statistical analysis and metrics to analyze those systems and processes being measured.

• Supports design control activities related to New Product Development and Sustaining Engineering. This includes risk management activities, MSAs, developing appraisal systems, component qualification and process validation activities.

• Accountable for setting own work direction and completing work tasks.

• May accomplish tasks through coaching and supervision of support and entry-level professional associates.

• Applies statistics to make decisions

• Ability to make and present risk-based decisions

• Prepares product and process reports by collecting, analyzing, and summarizing information and trends.

• Lead / support external (supplied component) and internal (manufacturing process) validations and associated activities for new products, existing processes, changes, and transfers as required.

• Participate on project teams as a Core Team Member or Leader

• representing manufacturing quality and / or quality processes

• Develop and implement new quality processes for production and scale-up programs and ensure successful quality goals

• Maintains a working knowledge of new methods, equipment, product specifications, waste, costs, through put rate, and material costs to be used in the justification of new equipment and cost reduction projects

• Prepares process descriptions and quality manufacturing specifications as required

• Provides technical guidance as needed to manufacturing and hourly technical personnel during the start-up of new or changed products and processes.

• Uses good decision making, problem solving and trouble-shooting techniques to minimize the potential or correct ongoing manufacturing quality issues.

• Ability to develop and create procedures, work instructions, templates / forms

• Initiates nonconformance reports when appropriate.

• Supports investigations and continuous improvement activities.

• Proposes improvements to processes and may be responsible for quality execution of a process or analysis.

• Applies knowledge and skills to a variety of standard and nonstandard activities.

• Works with minimal guidance in own area of knowledge.

• Other duties as assigned.

Requirements:

• Minimum of 3 years of related quality  experience in a manufacturing.

• Must have validation experience in manufacturing.

• Prior experience performing validations.

• Experience with SAP preferred

• Experience in Lean/Six Sigma preferred

• ASQ CQA, CQE, CMQ/OE preferred

• Computer proficiency in Microsoft Office (Word, Excel, Power Point, Outlook)

• Minitab or equivalent

• Ability to create and provide training

• Problem solving ability

• Ability to create, review and coordinate test protocols and reports

• Has knowledge and skills within the Quality Engineering Body of Knowledge.

Preferred Qualifications:

• Bachelor of Science degree in Engineering or related science

• CQE, CSSBB

• Experience leading / creating PFMEA and Control plans, applying knowledge of product, process, and observations from operators

• ISO 13485 - ISO 14971 - 12CRF820

• Supplier / Quality System Auditing

• PPAP Education and/or Experience

Physical Demands:
While performing the duties of this job, the employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment. The employee frequently is required to verbally communicate with other associates. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.