Quality Engineer (QMS) Job at BD (San Diego)

Quality Engineer (QMS)

BD

Location:
United States , San Diego

Category:
Quality Control

Contract Type:
Not provided

Salary:

124700.00 - 205800.00 USD / Year

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Job Description:

This role supports the execution of post-market quality processes by managing CAPA documentation, risk file alignment, and recall scoping activities. The position ensures accurate analysis of quality signals, facilitates CAPA investigations, and maintains compliance with regulatory requirements. It contributes to field action planning, prepares materials for internal and regulatory reviews, and provides data analytics to identify trends and support decision-making. Additionally, the role coordinates timely implementation of validated field action solutions and maintains audit ready documentation to uphold product safety and quality standards.

Job Responsibility:

Ensure that all CAPAs, Safety Alerts (SAs), Risk Assessments (RAs), Health Risk Assessments (HRAs), and Health Hazard Evaluations (HHEs) are aligned with the applicable risk files and determinations. Facilitate updates to risk documentation as needed to reflect current understanding and mitigations
Gather and organize data to identify affected units and customers. Assist in defining the scope of recalls and field actions, ensuring accuracy and completeness of impact analysis
Contribute to the development of presentations and documentation for internal Field Action Committee reviews and external regulatory communications. Ensure materials are clear, data-driven, and aligned with quality and regulatory standards
Drive timely development and implementation of field action solutions by analyzing complex issues, coordinating with collaborators, and ensuring solutions are robust, validated, and aligned with regulatory requirements
Ensure quality documentation is properly maintained and audit ready. Support audit preparation, execution, and response activities for both internal and external inspections
Analyze quality data to support investigations, identify trends, and generate reports. Use tools such as Excel, Power BI, or similar platforms to visualize performance and support decision-making
Track and manage the execution of field action solutions. Ensure that resolutions are robust, approved, validated, and released on time to customers. Coordinate with multi-functional teams to meet deadlines and regulatory commitments
Analyze Quality Data Trends (15% of Time) and prepare documentation for the facilitation weekly and daily management meetings with collaborators to review metrics and drive accountability. Maintain continuous tracking and reporting of performance indicators

Requirements:

B.S. Science, Engineering or other Technical Degree
Minimum 3 years in medical device quality or regulatory support
Demonstrates exceptional problem-solving skills by analyzing complex dynamics, understanding stakeholder perspectives, and driving timely development and execution of robust field action solutions
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, 21 CFR Part 820

Additional Information:

Job Posted:
January 13, 2026

Employment Type:

Fulltime

Work Type:

On-site work

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