Be part of something bigger at BD. Here, you’ll help us continually improve how we do things every day; to be more efficient, more effective and better serve our customers. You’ll do this within an exceptional team all striving to make sure that everything we do complies with regulations and standards, not just because it’s the right thing to do, but because our products impact people’s quality of life. Here, you’ll put your compliance experience, high expectations and attention to detail to the very best use: advancing the world of health™. At BD, you can make a true difference of one.
Job Description SummaryAs directed by the Senior Quality Manager, this position is responsible for assuring quality standards and regulatory compliance are consistent with Corporate and Division Policies, Government Regulations, International Standards, supporting the continued development, improvement and implementation of the Quality Systems within BDB Biosciences Business Unit.
Consistent application of Quality system standards
- Develops solutions to routine assigned activities of moderate/high scope & complexity.
- Follows applicable Company / Unit procedures and may make updates to procedures and policies.
- Works within and across functions for assigned Quality systems
- Working Knowledge of Quality Systems Regulatory requirements and application to Company /Unit requirements
- Develops applicable Site / Unit procedures / work instructions and may make updates to Unit level procedures and policies
- Guides the successful completion of major programs and may function in a project leadership role
- May perform other duties as required
Position Specific Overview
- Maintains and improves the BDB San Diego Quality System.
- Collaborates with cross functional partners to seek their input into the development of policies and procedures, Quality System manuals, and their support in addressing Quality Issues.
- Facilitates cross-functional interaction and communication between Quality, Regulatory Affairs, R&D, Regulatory Affairs, Manufacturing, Operations, Sales, and Marketing and other applicable teams to support in Quality System improvement and compliance.
- Participates and supports internal and external regulatory site visits, inspections, and audits. Including ensures that pre and post-inspection activities are completed including scheduling, record review, training, logistics, etc.
- Act as technical expert for regulations and standards including ISO 9001, ISO13485 & 21CFR820, requirements in support of global sites during external/internal audits and process harmonization.
- Assists with NB, Corporate and other regulatory, external and internal audit readiness and processes harmonization globally.
- Applies quality and/or standard-setting body requirements to develop solutions, control and/or maintain technical documents and/or Quality Systems.
- Routine communication with Notified Bodies and plants; including possible consolidation of NB and / or certificates.
- Trains, develops, and provides technical guidance to other associates.
- Actively participate in quality guidance and helps project & quality network teams for process improvement, standardization initiatives, and continuous improvement activities
- May serve as representative on BD Corporate Quality Networks, being responsible for implementing Network objectives at sites worldwide.
- Completes projects/other duties as assigned.
Scope of Responsibility:
- Develops advanced technological ideas and guides their development into a final product, process or business opportunity.
- Ensures the accurate and actionable recording of data for the making of decisions as well as to document development work
- Contributes to long-range business strategies, choosing disciplines and methods appropriate to the work content and context
- Outputs contribute to reduced cycle times, improved effectiveness and furthering the achievement of goals critical to company objectives
Sphere of Influence:
- Work is performed without appreciable direction.
- Assignments are often self-initiated. Determine and pursue courses of action necessary to obtain desired results.
- Plans and participates in disciplines strategically relevant to the business and/or functions
- Provides advice and mentors junior Associates
- Participates in, and may provide leadership for, multi-disciplinary projects
- Considered Site / Unit level Subject Matter Expert ( both process & IT applications) for site for assigned quality system
- May be assigned as Site / Unit member of Quality Systems Network team for assigned Quality systems element
Primary Work LocationUSA CA - San Diego (BDB)
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Advancing the world of health™
BD is one of the largest global medical technology companies in the world and is advancing the world of health™ by improving medical discovery, diagnostics and the delivery of care. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.
BD is unique in how fully dedicated it is to a specific disease state. It makes it clear how the work we do directly impacts the daily lives of the patients we serve.
Senior Director Quality Management
To know that our products touch 30 million people with diabetes around the globe is powerful and fuels our teams to deliver best in class products to them each and every day.
It is inspiring to see BD products to be used globally to advance human healthcare.
Manager Medical Laboratory