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 Manager, Quality Systems, the Staff Quality System Specialist I is responsible for assuring quality standards and regulatory compliance are consistent with Corporate and Division Policies, Government Regulations, International Standards and Standards of the Medical Device Industry; supporting the continued development, improvement and implementation of the Quality Systems within BD Medication Delivery Solutions (MDS) Business Unit.
Position specific responsibilities include support of the following, however are not limited to:
Maintains and improves the Franklin Lakes and WW MDS Quality System for assigned elements.
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 ensuring that pre and post-inspection activities are completed including scheduling, record review, training, logistics, etc.
Assists with FDA, MDSAP, 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.
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 a representative on BD Corporate Quality Networks, being responsible for implementing Network objectives at sites worldwide.
Completes projects/other duties as assigned.
Knowledge of US and International regulations and standards that apply to the medical device industry including FDA Quality Systems Regulations, ISO 13485, MDD, EU MDR, Canadian MDR, Japan PMDA as well as ANVISA and TGA requirements.
Consistent understanding of the application of quality systems to the medical device industry.
Industry recognized certification in a Quality System element specialty (e.g. ASQ Certified Quality Auditor, Quality Engineer) preferred.
Experience with Quality Management Systems, 8+ years (relevant experience or a combination of equivalent education and experience)
Experience in working directly with Notified Bodies and Regulatory Authorities preferred.
Prior experience managing internal and external audits.
Excellent communication skills at all levels both written and verbal.
Ability to set and deliver to specific goals and targets.
Ability to perform multiple tasks and prioritize workload.
Effective analytical, technical, and problem-solving skills.
Effective meeting and presentation skills.
Effectively manage conflict.
Ability to work in or direct teams to obtain results.
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
Primary Work LocationUSA NJ - Franklin Lakes
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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