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 Senior Quality Systems Specialist is accountable for support of the continued development, improvement, and implementation of the Quality System. This position actively participates in quality guidance and helps project & quality network teams for process improvement and continuous improvement activities.
Position-specific responsibilities include support of the following, however are not limited to:
Quality Systems (Franklin Lakes)
Maintains and improves the Franklin Lakes and WW Quality System, including key quality systems such as CAPA, Internal Audit, Supplier Management, Nonconformances, Analysis of Data, etc.
Collaborates with cross-functional partners such as Quality Engineering, R&D, Operations, Medical, Marketing to seek their input into the development of policies and procedures, and their support in addressing Quality Issues.
Develops training content and provides quality systems related training at unit and Plant locations
Performs Internal and Supplier audits
Participates in FDA, ISO, and other external audits. Ensures that pre and post-inspection activities are completed including scheduling, record review, training, logistics, etc.
Quality Systems (Worldwide)
Support EU MDR Post Market Surveillance providing data and supporting the preparation of Post Market Surveillance reports and plans for submission to regulatory bodies.
Interface with other functions to ensure accurate and timely completion and review of documents.
Conduct comprehensive literature searches, review of complaints, corrective and preventive actions, and MAUDE database and summarize in a report for medical devices.
Actively participate in quality guidance and helps project & quality network teams for process improvement and continuous improvement activities
Collect and Analyze Quality Data to assist with Management Review content development, CER, PMS, Quality Scorecard, etc.
Provide guidance and training to sites in various quality system areas such as CAPA, Internal audits, Supplier Management, Analysis of Quality Data, etc.
Supports quality system improvement and standardization initiatives within MDS
Skills and Knowledge:
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.
In-depth understanding of the application of quality systems to the medical device industry.
Experience with Trackwise and SAP
Advanced proficiency in data analysis tools such as Excel, Qlikview and BI report preferred.
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.
Ability to travel 10-15% (domestic and international)
Typically requires a minimum of a Bachelor’s Degree (preferred Life Sciences or Engineering)
Industry Recognized certification in a Quality System Element specialty (e.g ASQ Certified Quality Auditor, Quality Manager, Quality Engineer) preferred
A minimum of 5 years of relevant experience or a combination of equivalent education and relevant experience.
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
Additional LocationsUSA CA - San Diego TC Bldg C&D, USA CT - Canaan, USA NE - Columbus (West), USA UT - Sandy
What makes a successful Quality Professional at BD? Check out the top traits we’re looking for and see if you have the right mix.
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