Quality Systems Specialist - Laboratory

Job Description

We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of Med Tech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

The Quality Specialist supports laboratory operations by applying quality expertise across medical product testing activities, from test request initiation through report generation and archiving. This role ensures laboratory processes, systems, and activities consistently meet corporate quality standards, regulatory requirements, and business needs while driving continuous improvement and operational excellence.

• Coordinate and maintain a robust, standardized, and effective laboratory Quality System aligned with regulatory requirements and Quality Agreements.
• Serve as the local Subject Matter Expert (SME) for Quality Systems, ensuring compliance and providing guidance across the organization.
• Ensure laboratory processes, procedures, and organizational practices meet business needs and regulatory expectations.
• Promote a culture of quality and compliance, increasing awareness and understanding of ISO, QSR, and related regulations.
• Lead implementation and execution of Quality System processes to achieve performance and compliance objectives.
• Support and maintain document control and record management processes.
• Lead local implementation of annual Quality Objectives and Key Business Drivers for laboratory operations.
• Participate in and facilitate Quality Leadership meetings, ensuring actions are completed and quality initiatives progress effectively.
• Utilize metrics and performance reporting to monitor effectiveness, identify improvement opportunities, and deliver business value.
• Drive continuous improvement initiatives through lessons learned, best practices, and proactive problem prevention strategies.
• Support the development and maintenance of an effective local quality organization through training, mentorship, and knowledge sharing.
• Oversee and support:
  Training programs, curricula management, GMP and GDP compliance, Laboratory Information Management System (LIMS) operations, Quality Management System (QMS) audits, Metric data collection, analysis, and reporting, Management of nonconforming processes, ISO 17025 accreditation activities, Supplier quality management and Laboratory complaint investigations
• Assist with the execution of CAPAs, validations, calibrations, out-of-specification (OOS) investigations, and general laboratory quality activities.
• Plan, conduct, and participate in internal and external audits as required.
• Ensure compliance with applicable regulations and standards, including: ISO 13485, ISO 17025, 21 CFR Part 820 and Other applicable regional and regulatory requirements

• Bachelor’s degree in laboratory related science (Chemistry, Microbiology or related field).
• 2 years of experience in a laboratory associated with a regulated industry.

Knowledge and experience with Medical Device regulations, ISO 13485 and 21 CFR 820 as well as ISO 17025 2 years of experience in a laboratory in Med device or pharma industry ASQ Certified Quality Engineer, Quality Auditor Knowledge and

Skills:

Computer skills (Excel, Word, Power Point, etc.). Process oriented, Continuous Improvement Experience. Excellent organizational, analytical and process efficiency skills. Excellent interpersonal and communications. Project leadership skills. Initiative and drive for results.

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or…