Job Description SummaryDetermines 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.Job DescriptionWe are the makers of possibleBD 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 FUNCTIONSThe essential functions of this position include but are not limited to:
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. 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.
Ensure nonconforming product is properly contained. Completes required tasks once disposition decision has been made for nonconforming products. Provide complete F-HOLD ID for application on sterilized finished product.
Participate on nonconforming product investigation teams to help determine root cause and appropriate corrective action.
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.
Maintains the QA retention area, including filing and retrieving device history records and retention samples.
Monitors stocking location inventory. Makes necessary SAP transfers and supports inventory control in the hold area, including stocking location scrap transfers. Performs audits of hold areas as needed.
Troubleshoots basic weight check system issues.
Performs incoming, first piece, and final stat inspections, as required. Performs incoming inspection on material on the off shift or in the absence of incoming inspector.
Serves as a verifier and back up for the additive lab, verifying documentation when other lab personnel are not present and performing silica testing and additive checkout in the absence of lab coverage.
Conducts special sampling and product testing, as required. Pulls and provides tubes to the micro lab for testing as necessary.
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.
Supports Preventative Maintenance, as needed.
Completes other duties as assigned by QA Management.
OTHER RESPONSIBILITIESOther 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 supervisor.
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.
REQUIRED EDUCATION AND EXPERIENCE:Education
High School Diploma or equivalent
Associates Degree preferred
Experience
2+ years of QA/QC experience in a regulated experience is strongly preferred
Computer skills/experience required. Proficiency in Microsoft Office is preferred
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/careersBecton, 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, or any other protected status.Primary Work LocationUSA NE - Broken BowAdditional LocationsWork ShiftBecton, 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, or any other protected status.