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BD (Tissuemed Ltd) · 3 weeks ago

Quality Engineer (QMS)

San Diego, CA

Full-time

Onsite

Mid Level

$125K/yr - $206K/yr

3+ years exp

BD is one of the largest global medical technology companies in the world. The Quality Engineer (QMS) role supports post-market quality processes, including managing CAPA documentation and ensuring compliance with regulatory requirements, while analyzing quality data to drive decision-making and field action planning.

Health CareHospitalMedicalMedical Device

Responsibilities

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

Qualification

CAPARisk ManagementFDA DocumentationISO 14971ISO 13485ISO 900121 CFR Part 820Data AnalyticsExcelPower BIProblem-solvingOrganizational SkillsDetail-oriented

Required

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