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BD (Tissuemed Ltd) · 4 days ago

Staff Quality Engineer I - Sterilization

Hunt Valley, MD

Full-time

Onsite

Senior Level, Lead/Staff

$113K/yr - $187K/yr

6+ years exp

BD is one of the largest global medical technology companies in the world, and they are seeking a Staff Quality Engineer I to ensure product safety, quality, and compliance with global regulations. The role involves leading the sterility assurance program and managing a team of Quality Engineers to support sterilization and validation efforts.

Health CareHospitalMedicalMedical Device

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

Sterilization expertiseValidation experienceRegulatory knowledgeQuality system certificationSix Sigma methodologyProject management techniquesEffective communicationTeam leadershipProblem-solving skillsCross-functional collaboration