BD (Becton, Dickinson and Company) Quality Systems Engineer in Vernon Hills, Illinois
Job Description Summary
Summary/Purpose of Position
The position will support Quality Compliance functions within Quality Systems. Maintains the vital quality programs to ensure the Surgery Business Unit meets the Quality System requirements per BD procedures and applicable federal laws and international standards.
Essential Duties and Position Responsibilities
Execute and coordinate activities associated with Quality System requirements including, but not limited to, CAPA, root cause investigations and field remedial actions. Serve as site CAPA coordinator.
Serve as site CAPA Coordinator and lead all aspects of the corrective and preventive action system (CAPA) including analyzing the proposed actions in order to verify that the realized solutions will be effective; determining if the scope of the action is broad enough; and providing collaborative feedback to CAPA owners.
Lead functional groups to resolve root cause failure using standard failure analysis tools.
Maintain systems for supervising CAPAs and audit findings, perform trending analysis activities, and present information as appropriate to management.
Participate in and host CAPA Review Board meetings.
Perform regulatory standards reviews detailing as per procedure.
Execute product holds ensuring timely issuance, closure and EPR updates.
Management of Situation Analysis process and documentation for field action decisions.
Apply sound, detailed, problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Partner with cross-site and multi-functional resources in the pursuit of continuous improvement and provide quality systems mentorship.
Execute product Post Market Surveillance activities as requested.
Conduct and participate in internal and external Quality System audits to assess the compliance with FDA regulations, ISO standards, MDSAP, EU MDR and any other international laws and internal requirements.
Acquire and analyze information for the purposes of authoring and reviewing technical documents along with informative and decision-making management reports.
Maintain departmental processes and systems to ensure regulatory compliance.
Complete mandatory training by established due dates.
Support the generation, publishing, trending, and monitoring of Quality metrics.
Perform other duties as assigned.
Qualifications, Knowledge, and Skills Required:
Bachelor’s Degree required; preferably in Science, Engineering or Statistics.
2+ years of experience in quality systems/engineering, preferably in the medical device, pharmaceutical or biotech industry.
Proven understanding and application of quality tools, methodologies, and software (i.e., Is/Is Not Analysis, 5 Whys, Cause and Effect Diagram, Process Mapping, Pareto Analysis, Minitab, etc.) in the areas of investigations and CAPAs.
Applied Knowledge of the requirements of FDA QSR, ISO13485:2016 and ISO 14971:2012(US, EU, Canada, Japan, Australia) for medical devices.
ASQ CQA certification preferred.
Proficiency in common computer applications such as Microsoft Office (Excel, Word and PowerPoint).
Good interpersonal and phenomenal teammate skills including ability to work well with high degree of tact with representatives from a variety of fields.
Ability to work in a fast-paced, technically exciting environment where drive is critical to success.
Self-motivated, self-disciplined and able to prioritize and balance multiple tasks and responsibilities.
Willing to accommodate travel as needed.
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
Primary Work Location
USA IL - Vernon Hills
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.