BD · 19 hours ago
QA Quality Systems & Compliance Senior Manager
USA TX - El Paso - Northwestern Dr.
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
8+ years expBD is one of the largest global medical technology companies in the world, and they are seeking a QA Quality Systems & Compliance Senior Manager to lead the development and maintenance of quality management systems and compliance programs. This role ensures adherence to regulatory requirements and industry standards to support product quality and patient safety.
Health CareMedical DeviceTechnical Support
Responsibilities
Lead the design, deployment, and continuous improvement of BD’s Quality Management Systems (QMS), including document control, CAPA, change control, deviation management, audit management, post market compliance and training systems
Ensure compliance with global regulatory requirements such as FDA, EMA, ISO 13485, GMP, and GxP standards
Develop, review, and maintain quality policies, procedures, and work instructions aligned with BD’s corporate standards and regulatory expectations
Manage internal and external audits, including regulatory inspections, internal audits, and customer audits, ensuring timely and effective resolution of findings
Collaborate cross-functionally with Manufacturing, Engineering, Regulatory Affairs, Supply Chain, and other stakeholders to embed quality and compliance into operational processes
Oversee quality management programs to ensure compliance with BD’s quality standards
Lead root cause investigations, situation analysis and risk assessments related to quality system deviations and non-conformances
Provide leadership, coaching, and development to the Quality Systems and Compliance team, promoting a culture of accountability and continuous improvement
Monitor and report on key quality metrics and compliance KPIs to senior leadership, identifying trends and areas for improvement
Support regulatory submissions and inspections related to quality systems and compliance
Drive training and awareness programs to ensure all employees understand their roles in maintaining quality and compliance
Oversee the function and lead the compliance of C2C technical training, assuring the training of new associates and retraining as required
Lead quality system projects and initiatives that support BD’s business objectives and regulatory changes
Qualification
Required
Bachelor's degree in Life Sciences, Engineering, or related field
Experience managing teams
strong leadership, communication, and interpersonal skills with the ability to influence at all levels
Proven track record managing quality systems
deep knowledge of regulatory requirements (FDA, EMA, ISO 13485, GMP, GxP)
industry best practices
Experience managing audits and regulatory inspections
Proficiency with quality management software and Microsoft Office Suite
Excellent analytical, problem-solving, and decision-making abilities
Ability to work effectively in a global, cross-functional team environment
Preferred
advanced degree preferred
Minimum 8-10 years of progressive experience in quality assurance within pharmaceutical (preferred) and/or medical device manufacturing
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
Richard Byrd
Executive Vice President and President Interventional Segment
Recent News
2026-01-22
Medical Device Network
2026-01-22
Company data provided by crunchbase