This job is currently Archived,
Quality Shift Leader - United States
Becton Dickinson (company)
Posted on : 04 April 2017
- Determines final release of product leaving, 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.
The 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 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.
- Maintains the QA retention area, including filing and retrieving device history records and scrapping.
- 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 and resets Infinity passwords.
- Performs incoming 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 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.
EDUCATION, EXPERIENCE AND SKILLS REQUIRE
- High School diploma or equivalent
- Minimum of an Associate’s Degree is strongly preferred
- 2+ years of QA/QC experience
- Experience within a regulated industry is strongly preferred
- Computer skills/experience is required. Proficiency in Microsoft Office is preferred.