B. Braun Medical Inc. (US) · 3 hours ago
Sr. Director Quality
Irvine, CA
Full-time
Onsite
Director/Executive
$211K/yr - $301K/yr
15+ years expB. Braun Medical Inc. is a leader in infusion therapy and pain management, dedicated to enhancing patient safety through innovative medical products and services. The Sr. Director Quality will provide enterprise-level leadership for the Quality function, ensuring compliance and product quality while developing long-term strategies aligned with corporate objectives.
BiotechnologyMedical DeviceEducationHealthcareManufacturingPharmaceuticalClinical TrialsHealth Care
Responsibilities
Provides enterprise‑level leadership for the organization’s Quality function, setting strategic direction and ensuring sustained compliance, product quality, and patient safety
Develops and executes long‑term Quality strategies and multi‑year roadmaps aligned with corporate, franchise, and operational objectives
Establishes, governs, and continuously improves the organizational Quality Management System (QMS), ensuring effectiveness, scalability, and regulatory readiness
Anticipates, identifies, and mitigates systemic quality risks, including potential quality failures across materials, manufacturing, processes, systems, and supply chain
Defines and oversees robust mechanisms for evaluation of raw materials, components, in‑process goods, finished products, and quality systems, ensuring timely and effective corrective and preventive actions
Champions a strong quality culture through leadership behaviors, governance, accountability, and continuous improvement
Solicits and integrates internal and external stakeholder feedback, regulatory intelligence, and industry best practices to drive sustained performance improvement
Serves as the senior Quality representative during external regulatory inspections, audits, and high‑impact customer or partner engagements
Provides executive oversight of recurring and critical Quality operations, ensuring efficient execution while identifying opportunities for simplification, standardization, and efficiency
Allocates and optimizes resources, budgets, and investments in alignment with business priorities and risk‑based decision making
Leads and develops a senior Quality leadership organization (Directors, Senior Managers, Managers, and professionals), with full accountability for hiring, development, performance management, succession planning, and organizational design
Acts as a key contributor to enterprise strategic planning, business reviews, and executive decision‑making forums
Establishes, recommends, and approves Quality policies, practices, and procedures with significant organizational and regulatory impact
Functions as the management representative for Quality in accordance with organizational policies and applicable laws and regulations
Holds ultimate Quality accountability for assigned sites, functions, and product portfolios
Qualification
Required
Bachelor's degree in a scientific, engineering, or related discipline required
15+ years of progressively responsible experience in Quality within a regulated industry (pharmaceutical, biotechnology preferred)
8+ years of senior leadership experience managing complex, multi level Quality organizations
Demonstrated experience with enterprise or multi site Quality oversight and regulatory engagement
Extensive breadth and depth of organizational, technical, regulatory, and industry knowledge
Ability to integrate complex information across multiple disciplines and business units
Strategic thinker with strong execution capability
Demonstrated executive presence, influencing, and decision making skills
Proven ability to lead through ambiguity, risk, and organizational change
Champions advanced Quality strategies, governance models, and continuous improvement methodologies
Occasional business travel required
Valid driver's license and passport
Secrecy and invention agreement and non- compete agreement
Regular and predictable attendance
Preferred
Master's degree or advanced degree preferred
Applicable industry/professional certification preferred
Benefits
Healthcare
A 401(k) plan
Tuition reimbursement
Company
B. Braun Medical Inc. (US)
B.
10001+ employees
H1B Sponsorship
B. Braun Medical Inc. (US) 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
2025 (16)
2024 (10)
2023 (14)
2022 (6)
2021 (12)
2020 (9)
Funding
Current Stage
Late StageTotal Funding
$0.03MKey Investors
Ben Franklin Technology Partners of Northeastern Pennsylvania
2020-10-27Debt Financing· $0.03M
Leadership Team
Leigh Ann Stradford
Senior Vice President and Chief Human Resources Officer
Rob Albert
Senior Vice President and Chief Marketing Officer/ Senior Vice President of Marketing
Recent News
2026-02-12
The Morning Call
2026-02-03
Company data provided by crunchbase