3045 Becton Dickinson Global Services Centre is hiring a Quality Engineer (QMS) to support post-market quality processes. This role is central to managing CAPA documentation, aligning risk files, and scoping field actions to ensure product safety and regulatory compliance.
What You'll Do
- Ensure all CAPAs, Safety Alerts, Risk Assessments, Health Risk Assessments, and Health Hazard Evaluations are aligned with applicable risk files.
- Facilitate updates to risk documentation to reflect current understanding and mitigations.
- Gather and organize data to identify affected units and customers for field actions.
- Assist in defining the scope of recalls and field actions, ensuring accurate impact analysis.
- Contribute to developing presentations and documentation for internal Field Action Committee reviews and external regulatory communications.
- Drive timely development and implementation of field action solutions by analyzing complex issues and coordinating with collaborators.
- Ensure all quality documentation is properly maintained and audit ready.
- Support audit preparation, execution, and response activities for internal and external inspections.
- Analyze quality data to support investigations, identify trends, and generate reports.
- Track and manage the execution of field action solutions.
- Coordinate with multi-functional teams to meet deadlines and regulatory commitments.
- Analyze Quality Data Trends and prepare documentation for weekly and daily management meetings to review metrics.
What We're Looking For
- B.S. in Science, Engineering, or another Technical Degree.
- Minimum 3 years of experience in medical device quality or regulatory support.
- Familiarity with CAPA, risk management, and FDA documentation.
- Strong writing and organizational skills.
- Detail-oriented and comfortable working in a fast-paced environment.
- Knowledge of ISO 14971, ISO 13485, ISO 9001, and 21 CFR Part 820.
Technical Stack
- Excel
- Power BI
Benefits & Compensation
- Salary range: $124,700.00 - $205,800.00 USD annually.
Work Mode
This position is hybrid, based in USA CA - San Diego TC Bldg C&D.
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally-protected characteristics.
