BD (Becton, Dickinson and Company) Quality Technician II - A Shift (MDS) in Holdrege, Nebraska
Job Description Summary
Be part of something bigger!
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. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.
Hours : 6:30 AM to 6:30 PM
The Quality Technician II duties include: Support manufacturing by providing guidance regarding quality documentation/specifications, provide assistance with quality notifications,/rejections to ensure product is properly contained, partner with quality engineers and manufacturing to investigate root cause of manufacturing and/or customer complaint related issues and prevent reoccurrence, assist Quality and Process Engineers with inspections/testing associated with validations and engineering studies, use SAP to complete material movements.
In addition, the Quality Tech II will review and file the Device History Record (DHR) created as evidence of each lot/batch produced in Holdrege and the subsequent release of the DHR within the SAP system. This requires the review of the records that make up the product DHRs and verification that the inputs on the forms meet the requirements. The Quality Tech II will also create quality notifications and assist in documentation and product investigation when discrepancies within the DHR are detected.
ESSENTIAL FUNCTIONS :
Essential functions include but are not limited to:
Give direction concerning product quality using quality documentation.
Work with Team Leaders and Quality Engineers to ensure QNs are handled properly.
Work with Quality Engineers and Manufacturing to improve quality and reduce QNs.
Complete ZE, ZM and ZV notifications completely and accurately within the SAP system.
Provide training to associates regarding product sort or rework activities as Temporary Inspection Plans as necessary.
Assist with making changes to documents within SAP as necessary. Utilize SAP/Flexnet for product hold and release.
Perform Device History Record review and acceptance activities according to approved quality system documentation.
Understand, use and enforce ISO Standards and FDA regulations. Read, interpret and explain specification and drawings as required.
Train and certify co-workers in inspection techniques and using gauges for inspection.
Work flexible hours to support manufacturing.
Maintain the accurate filing of DHR documentation.
Maintain the accurate filling of Change Control Documents (EWO), validations, TIPs, etc.
Knowledge of the linkages associated with the administration of the quality system records.
Maintain paper record files onsite and offsite (as required) to prevent deterioration and facilitate look up and/or recovery.
These records include: DHR, Validations, TMV's, EWO's, FAT's SCR's, etc. Knowledge of Sterilization/Warehouse procedures (label control, bar code, scheduling of product, etc.)
Provides key support to validation activities.
Provide tracking of the components, subassemblies, and finished goods associated with validation product.
Provide final review of DHR records associated with any validation product identified as approved for release.
Support completion of EWO activities as directed to ensure all documentation is completed and filed appropriately.
Support internal and external audits as necessary. Provide key support to electronic record conversion from transference of paper records to creation of records electronically.
In some cases, manage the work being performed in non-conforming product sort areas.
- Performs other duties as assigned by Team Leader and required to support the needs of the business.
CONDITIONS OF EMPLOYMENT IN THIS DEPARTMENT:
Employees: must obey safety programs, policies & regulations; must follow all GMP/QSR rules; must cooperate fully with the safety and environmental programs; must be able to work in a team environment and fully cooperate with co-workers and management; may not pose a direct threat or significant risk to themselves or others; must have regular attendance.
CONDITIONS OF EMPLOYMENT IN THIS FACILITY:
The "Essential Functions" and "additional Responsibilities" listed in this description do not restrict the addition or deletion of any other responsibilities to this position. 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 successfully. Management reserves the right to change any and all job description without notice and business conditions dictate.
Continuous & Versatile Learning
Dealing With Ambiguity
Drive for Results
We do what is right
JOB QUALIFICATIONS :
REQUIRED: H.S. Diploma/GED (if hired after 6/1/00). Internal transfers exempted.
PREFERRED: Associates Degree or higher (Major: Manufacturing, Quality or related field)
2. Experience and Knowledge
2 years in quality/FDA regulated manufacturing environment preferred.
Previous inspection or manufacturing quality experience.
Proficient looking up Quality Specifications using SAP software
Proficient using precision measuring instruments and able to give direction to others.
Proficient with inspection methods and documentation.
Proven interpersonal and communication (verbal and written) skills.
Demonstrated problem solving and decision-making skills.
Well-developed planning, organization and prioritization skills.
Able to work with minimal direction/supervision.
- Certification or licensure preferred: Certified Quality Technician (CQT) preferred.
4. Supervisory Responsibility
No supervision of others
May be required to take a leading role, such as managing some activities of other associates (less than 50% of the time).
5. Computer skills preferred for position
Basic keyboarding and navigational skills
Flexnet experience preferred
Why join us?
A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.
To learn more about BD visit https://jobs.bd.com/
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action al 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 Location
USA NE - Holdrege
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, or any other protected status.