Job Description SummaryAbout BD: 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. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 65,000 employees have a passion and commitment to help improve patient outcomes, improve the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to better diagnose disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. In 2017, BD welcomed C. R. Bard and its products into the BD family. For more information on BD, please visit bd.com. Job Description
The QM Engineer I is responsible for gaining experience in the application and interpretation of the plant/department procedures to ensure consistency/compliance with Quality Systems.
Learning to apply the Quality Systems to ensure compliance as well as having the knowledge necessary to apply the appropriate statistical and analytical tools. Works with various enterprise systems/Corporate directives to support new and/or current product lines and processes.
Typical assignments may include: developing/implementing tasks associated with plant activities or projects of general complexity within planned schedules/timelines, supporting audits, trending and reporting on product data, participating on teams, ensures documentation compliance, processing complaints, CAPAs, change control, and deviation waivers. Routine interaction with other functional areas such as Operations and other Quality groups.
DUTIES and responsibilities
The Quality Engineer is primarily responsible for reviewing and assessing Quality Notifications, Complaints, Deviation/Waivers and other cGMP activities for the assigned product lines in the instrument plant. The QM Engineer I oversees QC operations within the instrument plant and assuring documentation and procedures are followed, updated and maintained as required by internal Quality Policies and related FDA/GMP guidelines. The QM Engineer I conducts complaint investigations, assists in the investigation of manufacturing issues and provides data and input on technical issues and projects.
Cost Center Specific:
- Manage compliant handling, QN's, CAPA's, D/W's and trending for assigned instrumented platforms. Assist manufacturing in maintaining compliance with cGMP associated with the quality system procedural requirements for assigned platforms.
- Drives for continuous improvement in all areas and participates on Continuous Improvement teams and recommends improvements, implements changes and verifies effectiveness of changes
- Performs all duties in accordance with all applicable BDDS Quality, Safety and Operating Procedures.
- Work collaboratively with suppliers to part quality.
- Ability to identify Quality issues and recommend corrective actions that can lead to resolution of general or routine complexity.
- Accesses policies and procedures for guidance.
- Capable of using Microsoft programs and ability to learn other systems.
- Basic knowledge of statistical methods and quality tools, as well as statistical application software.
- Effective verbal and written communication skills.
- The ability to work in teams, independent of supervision, to obtain planned results.
- Must be self-motivated, organized, detail oriented and have ability to multi-task.
- BS or BA in related field required with no experience required.
- Typical degree in Biological Sciences, Chemistry, and Engineering, Computer Science and/or Regulatory Affairs or other related field.
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.
Primary Work LocationUSA CA - San Jose Additional Locations Work Shift
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.