Job Description Summary

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 primary responsibilities of the Quality Engineering Assistant - Process are in alignment of those with a quality shift lead (see section 1.2). The position will flow to work as instructed by quality management in the areas of Quality Engineering as an area of second responsibility (section 1.3) and Incoming Inspection as third priority (section 1.4).  Determines final release of product leaving Broken Bow, reviews device history records for complete and proper documentation for meeting product requirements to release.  Supports inventory control of product on hold.  Monitors production processes and product quality and makes decisions regarding the acceptability (from a Quality standpoint) of in-process and finished product. Maintains and manages the record QA retentions area. Supports special project activities, Factory Work Orders (FWO’s) and process/product validations. This role is utilized as a source of critical information for scheduling, sterilization, production, and shipping. 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/O’s; Serves as backup for incoming inspection. Inspects, analyzes, and determines the acceptability of incoming materials using statistical sampling to assure incoming materials meet quality levels; Administers product testing procedures; Assures that GMP and ISO requirements are met regarding the storage and issuance of raw materials for production; Coordinates supplier notifications and/or disposition and control of nonconforming materials.  Writes, revises and/or originates all types of documents, forms and policy procedures and releases.  Supports inventory control of product on hold.  Supports special project activities, Factory Work Orders (FWO’s) and process/product validations.

ESSENTIAL FUNCTIONS

• Determines the final release status of finished product. Completes necessary documentation and identifies product as being released. Reviews DHR's for proper documentation and inputs necessary data in SAP. Last check before product is released.

• Functions as a trainer on how to complete appropriate functions of Batch Final Packer functions.  Assists in training production associates on revised procedures and forms, as required.

• Are key in making decisions using appropriate specifications and documents regarding the acceptability of materials, in-process and finished product.  Completes Material Review Notices (defect notifications), scrap memos, certifications and statistical sampling, as required.

• Communicates effectively, both verbally and in writing, with all levels of Plant personnel to report product quality issues and out-of-specification conditions.  Interfaces with 100% inspection personnel to facilitate effective inspection and to coordinate product flow. Interfaces in audit situations both face to face and as a resource as needed.

• Reads and interprets product specifications, Plant procedures and current ISO, ANSI/ASQC and TAPPI standards to determine inspection and product acceptance requirements.

• Conducts device history and procedural audits as directed by QA Management.

• Performs incoming and final stat inspections, as required. Performs incoming inspection on material in the absence of incoming inspector.

• Conducts special sampling and product testing, as required.

• Collects product/process data for FWO’s, special projects, validations, etc., as required.

• Supports collection of data to monitor product quality trends and defect notifications in SAP.

• Performs inspections and determines release on labels for outside customers, banding mats, stoppers, TNT tubes, etc.

• Assists in revising specifications, policies, procedures, and forms, as necessary.

• 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 needed.

• 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/O’s 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 MSA’s, collecting, organizing and processing data.

• Fluently interfaces/communicates with personnel from Division, other B-D plants or external suppliers.

• Provide support for internal audits, third party regulatory audits and customer complaints as required. 

• Completes other duties as assigned by QA Management.

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.

SUPERVISION

• This position reports directly to the applicable Quality Manager or Quality Engineer.

Education and Experience:

Education

• Associates degree or commensurate experience required

• Bachelor’s degree strongly preferred.

Experience

• Two years of quality control/quality assurance experience required. Previous experience with inspecting and/or verifying the quality of products produced meets specified requirements and releasing final product, strongly preferred.

• Experience in execution and understanding of validation protocols (IQ/OQ/PQ, MSA’s, training to protocol, collection of supporting documentation, update of SOP’s) is strongly preferred.

• Previous experience in writing of validation, study, and MSA protocols strongly preferred.

• Previous experience in SOP creation or update and approval collection is required.

Knowledge and Skills:

Mental Requirements

• Strong verbal, written and analytical skills. Ability to use all basic mathematical operations (i.e. multiplication and division), including proper use of rounding techniques.

• Experience using Minitab strongly preferred.

Equipment Use

• Ability to manually operate a computer with a standard keyboard, standard calculator, electronic balance and other measuring instruments and gauges as required.  The ability to operate manual pallet movers.  The ability to operate an optical micrometer, force gauges, balances, and various other measurement tools.

Physical Demands: (if applicable)

Physical Requirements

Level 3

• Medium Work:  Exerting 20 to 50 pounds occasionally or 10 to 25 pounds frequently, or up to 10 pounds constantly.  Physical demands requirement are in excess of those for Light Work.

• Ability to lift 40 pounds and/or push 100 pounds.

• 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.

Work Environment: (if applicable)

Working Conditions

• The position is subject to inside environmental conditions. Protection from weather conditions but not necessarily from temperature changes.

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.

#earlycareer

Required Skills

Optional Skills

.

Primary Work Location

Additional Locations

Work Shift