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.

JOB SUMMARY:

The Quality Engineering Assistant tests product and/or components for function; Collects and analyzes data; Plans and coordinates special project activities/Factory Work Orders; Administers product testing procedures; Executes and/or supports plant studies and validations; Writes and/or revises all types of documents, forms, and policy procedures; Writes/Originates ECR/Os; Serves as backup for incoming inspection.

EDUCATION:

• Associate’s degree or commensurate experience required.
• Bachelor’s degree strongly preferred.

EXPERIENCE:

• Experience in execution and understanding of validation protocols (IQ/OQ/PQ, MSAs, training to protocol, collection of supporting documentation, update of documents) is strongly preferred.
• Previous experience in writing of validation, study, and MSA protocols strongly preferred.
• Previous experience in manufacturing document creation, update, and approval is required.
• Experience leading and/or supporting Six Sigma projects preferred.

MENTAL REQUIREMENTS:

• Strong verbal, written and analytical skills. Ability to use all basic mathematical operations (i.e. multiplication and division), including proper use of decimals.
• Experience using Minitab strongly preferred.

PHYSICAL REQUIREMENTS:

Level 2

• Light Work: Exerting up to 20 pounds occasionally, and/or 10 pounds of force frequently, or negligible constantly. Walking or standing to a significant degree or sitting constantly and pushing/pulling controls.
• A visual acuity analysis must be successfully completed or on file for associates entering this position. A valid driver’s license will also be an acceptable substitute for the visual requirement.

ESSENTIAL FUNCTIONS:

The essential functions of this position include but are not limited to:

• Manages change control, validation, and other quality system documentation.
• Sets up and conducts experiments to provide meaningful data for analysis and submits final reports.
• As a validation practitioner, writes, executes, and reports on validations.
• As a validation contributor and supporter, provides help and support for the execution and data gathering associated with validations.
• Uses current documentation system to revise/write all types of specifications, forms, and Policy/Procedures, as well as writing/originating ECR/Os and data storage/ analysis. May perform administrative duties in current documentation system as assigned.
• Runs Factory work Orders and performs product testing for new or redesigned products/ processes, line extensions, customer complaints, and in-plant quality issues.
• Conducts Process Capability Studies and MSAs, collecting, organizing, and processing data.
• Fluently interfaces/communicates with personnel from Division, other BD plants, or external suppliers.
• Provide support for internal audits, third party regulatory audits and customer complaints as required.
• Serves as backup for incoming inspection functions, as necessary.
• Measures and tests incoming materials and finished products per specifications and test procedures using the latest equipment and technology/inspects material visually for specified characteristics.

OTHER RESPONSIBILITIES:

Other responsibilities of this position include but are not limited to:

• Complies with all local, state, federal and BD safety regulations, policies/procedures.
• Complies with all local BD quality policies/procedures/practices through consistent application of sound Quality Assurance principles.
• Performs other job-related duties as assigned.
• Observes all safety, environmental and quality system standards.
• All requirements are subject to possible modification to reasonably accommodate individuals with disabilities.
• Some requirements may exclude individuals who pose a direct threat or significant risk to the health and safety of themselves or other employees.
• This job description in no way states or implies that these are the only duties to be performed by the employee occupying this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by their facilitator.
• Requirements are representative of minimum levels of knowledge, skills and/or abilities. To perform this job successfully, the incumbent will possess the abilities or aptitudes to perform each duty proficiently.
• This document does not create an employment contract, implied or otherwise, other than an “at will” employment relationship.