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 Manager, Quality, Distribution Operations. The Quality Systems Specialist is accountable for working cross functionally in the application, understanding and compliance of their assigned Quality Systems.
Ensures applicable Quality Systems comply with current ISO 13485, 21 CFR 820 and corporate requirements.
Ensures the accurate and actionable records for the making of decisions.
Ensures distribution processes follows applicable released procedures.
Contributes to long-range Supply Chain strategies, choosing disciplines and methods appropriate to the work content and context.
Outputs contribute to reduced compliance risks, improved effectiveness and furthering the achievement of goals critical to company objectives
Primary Responsibilities and Duties
1. Responsible for Quality Systems as assigned,
2. Responsible for application of assigned Quality Systems in a manner that meets the scope of storage and distribution processes.
3. Responsible for monitoring assigned Quality System performance through established metrics and/or Quality objectives, addressing under performance and escalation with appropriate leadership when required.
4. Collaborates with functional process owners to train, mentor and/or facilitate QMS requirements, continuous process improvement and audit support.
5. Maintains awareness, follows applicable Corporate Quality procedures and may make updates to procedures, policies, training matrixes and curriculums.
- The Quality Systems Specialist will be accountable for Quality Systems as the local Subject Matter Expert (SME), providing guidance and training, facilitating meetings, escalation and ensuring compliance to the following Quality Systems as assigned:
- Document and record control, DMS Administrator
- Training & Curricula / C2C DLA / GMP & GDP
- Order Fulfillment Claims support for root cause analysis and SCARs
- Intracompany Claims
- QMS Audits
- Metric Data Analysis
- Product Hold Backup
- Maintain awareness, train and mentor distribution functions as the SME for the Quality Systems assigned as well as applicable requirements from ISO 13485, 21 CFR 820 and Corporate Policies / Procedures when appropriate.
- Where assigned, responsible for ensuring site is meeting the terms and obligations of local wholesale drug licenses as the Designated Representative.
- Participate and represent Distribution Quality on projects, implementations and initiatives associated with regional improvement goals, annual Quality objectives, integration and optimization as assigned.
- Other duties and responsibilities as assigned.
Sphere of Influence:
Works under general direction.
Determine and pursue courses of action necessary to obtain desired results.
Plans and participates in disciplines strategically relevant to the business and/or functions
Participates in, and may provide leadership for, multi-disciplinary projects
Considered Site / Functional Subject Matter Expert (both process & IT applications) for assigned processes.
May be assigned as Site / Functional member of Quality Systems Network team for assigned Quality systems element
Sharing of best practices across local and regional sites and functions
* Working knowledge and application of ISO 13485 and 21 CFR 820.
* Subject matter expert of Quality Systems Regulatory requirements and application tools
* Excellent communication, problem solving, organizational and interpersonal skills are essential.
A minimum of 5 years relevant experience or a combination of equivalent education and relevant experience in Medical Device and/or Pharmaceutical regulated industry within Quality, Supply Chain and/or Distribution Center operations.
Computer skills (Excel, Word, Power Point, etc.)
Self-motivated and directed, requiring minimal supervision
Demonstrated ability to work in teams to obtain results is required.
Effective skills in analytical thinking and problem solving required
BS Degree in Quality Engineering, Supply Chain or related Science discipline preferred or a combination of equivalent education and experience.
Certifications (if applicable)
Industry Recognized certification in a Quality System Element specialty, (e.g ASQ Certified Quality Auditor, etc.) preferred.
Experience (indicate the number of years) )
Primary Work LocationUSA CA - Redlands Distribution Ctr
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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