Be part of something bigger at BD. Here, you’ll join a driven, agile engineering team working in a startup-like environment that has the backing and resources of a Fortune 500 company. In engineering, you could be involved in everything from operations, production and construction to information technology and maintenance environments, all while analyzing and developing solutions to further our engineering capabilities. You’ll use your talent and track record of solving complex problems to achieve one singular goal: advancing the world of health™. At BD, you can make a true difference of one.
Job Description SummaryReporting to the Director of Quality, this role develops and implements effective data analysis and visualization for all of Post Market Surveillance and Quality Management Systems (QMS) within and support of BDB business. These activities are in direct support of monitoring and detecting quality and safety signals associated with product performance (e.g., adverse events, product malfunctions) as well as QMS performance. This role ensures on-going regulatory compliance and continuous product and QMS improvement.
Values – Our Standard of Behavior
- We do what is right
- We thrive on innovation and demand quality
- We are all accountable
- We learn and improve every day
- We help each other be great
Our Mindset – The attitude we bring to our work
- Speaking up builds trust and gets to better outcomes faster
- Inclusion and diversity make us a stronger team
- Keeping it simple enables innovation and agility
- The best way to help customers and patients is to truly know them
- Challenges are opportunities to grow and improve
Leadership Commitments – How we lead ourselves and our work
- Be bold and strategic
- Remove obstacles and empower others
- Deliver results that matter
- Debate and decide, then commit and go
- Have the courage to iterate, try new things and embrace change
- Collect and Analyze Quality Data to assist with Management Review content development, CER, PMS, Quality Scorecard, etc.
- Assures the data integrity of all output via appropriate verification and validation activities.
- Ability to document statistical-based trending procedures and trending analysis validation in compliance with regulatory requirements
- Support 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
- Provide guidance and training to sites in Analysis of Quality Data
- Supports quality system improvement and standardization initiatives within BDB
- Support internal and external audit/inspection for area of responsibilities
EDUCATION AND EXPERIENCE REQUIREMENTS
- 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/IVDR, 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.
- Self-motivated /directed.
- 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.
Primary Work LocationUSA CA - San Jose
What makes a successful Engineer Professional at BD? Check out the top traits we’re looking for and see if you have the right mix.
- Team player
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.
As a new employee what I like most about BD are the many learning and professional developmental opportunities for growth offered. It is good to know that there are so many resources to choose from.
Since joining BD, I really have liked the people I work with on a daily basis and the collaboration towards common goals.
Senior Program Manager
BD is full of passionate, loyal, and driven people that have a common goal of advancing healthcare without sacrificing quality or service.