BD · 3 weeks ago
Quality Engineer (QMS)
USA CA - San Diego TC Bldg C&D
Full-time
Onsite
Mid Level
$125K/yr - $206K/yr
3+ years expBD is one of the largest global medical technology companies in the world, focused on advancing health. The Quality Engineer role involves managing CAPA documentation, risk file alignment, and recall scoping activities, while ensuring compliance with regulatory requirements and supporting decision-making through data analytics.
Health CareMedical DeviceTechnical Support
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
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
Benefits
Competitive package of compensation and benefits programs
Rewards and recognition opportunities
Company
BD helps advance clinical therapy with the process for patients and health care providers with innovative technology services and solutions.
10001+ employees
H1B Sponsorship
BD has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (66)
2022 (4)
2021 (3)
Funding
Current Stage
Public CompanyTotal Funding
$540MKey Investors
Steris
2023-08-02Post Ipo Equity· $540M
1962-04-23IPO
Leadership Team
Tom Polen
Chairman, CEO and President
Maureen Mazurek
Chief Sustainability and EHS Officer
Recent News
2026-01-16
Med-Tech Insights
2026-01-16
Pharmaceutical Technology
2026-01-16
Company data provided by crunchbase