BD · 8 hours ago
Staff Quality Engineer I - Sterilization
USA MD - Hunt Valley
Full-time
Onsite
Senior Level, Lead/Staff
$113K/yr - $187K/yr
6+ years expBD is one of the largest global medical technology companies in the world. The Staff Quality Engineer I is responsible for ensuring product safety and quality, managing sterility assurance programs, and leading a team of Quality Engineers in compliance with global regulations.
Health CareMedical DeviceTechnical Support
Responsibilities
Sterility Assurance Champion: Lead our comprehensive site sterility assurance program across multiple sterilization modalities (ethylene oxide, radiation, moist heat, dry heat, and aseptic processing). Interpret ISO standards and translate corporate policies into actionable local procedures
Strategic Prioritization: Drive key site sterilization initiatives, validation projects, and supplier management objectives with a focus on continuous improvement and innovation
Quality Leadership: Provide expert recommendations to align site sterilization and microbiology capabilities with segment strategy, ensuring our validation team is properly resourced to meet regulatory requirements
Validation Excellence: Develop and maintain the site-level Validation Master Plan, establishing the foundation for all validation activities
Cross-Functional Collaboration: Build influential relationships with leadership team members to identify quality improvement opportunities and implement new processes that optimize efficiency
Problem-Solving Catalyst: Foster an environment of critical thinking, innovation, and rapid issue resolution to address complex sterility challenges
Project Leadership: Spearhead special projects aligned with team goals to meet microbiological, sterilization, and supplier management strategic priorities
Supplier Management: Guide strategic sourcing/procurement teams in qualifying and managing contract sterilization and testing suppliers
Technical Expertise: Serve as the site's sterilization subject matter expert for process development, manufacturing environment design, test failure investigations, and audit responses
Metrics & Monitoring: Establish robust systems to track, report, and monitor sterility assurance and validation metrics, providing proactive recommendations for addressing negative trends
Quality Advocacy: Manage customer-impacting issues with a commitment to upholding the highest quality and compliance standards
Regulatory Knowledge: Apply working knowledge of FDA medical device regulations and international quality standards (21 CFR Part 820, ISO 13485, MDSAP, EU MDR/IVDR)
Best Practice Sharing: Act as segment liaison among plants, businesses, and functions to communicate metrics, best practices, and successful technology advances
Inspirational Leadership: Lead by example as a recognized subject matter expert in validation and sterility assurance
Team Development: Mentor and develop personnel with dedicated succession planning and contingency management
Knowledge Transfer: Train site/business unit members on sterility assurance principles and practices
Industry Engagement: Participate in external technical associations (ISO, ASTM) related to sterilization, microbiology, and contamination control
Audit Support: Provide expert guidance during sterility assurance and technical audits
Team Leadership: Lead and inspire a talented team of sterility assurance and validation quality engineers
Qualification
Required
Bachelor's degree in Engineering, Microbiology, Biology, Medical, Technology or life science
6 years of experience in sterilization, microbiological and/or supplier management in medical device and/or healthcare industry
Demonstrated experience in handling and gaining consensus across cross functional teams within sites
Preferred
Industry Recognized certification in a Quality System Element specialty (e.g ASQ Certified Quality Auditor, Quality Manager, Quality Engineer)
Experience or training with Six Sigma methodology and project management techniques
Related Standards Management experience (ISO, ASTM…)
Auditing experience and certification as a technical auditor
Benefits
A valuable, competitive package of compensation and benefits programs
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 of the BD Interventional Segment
Recent News
EIN Presswire
2026-01-09
Company data provided by crunchbase