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.
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Job Type:
Full-Time -
Job Level:
Entry to Senior -
Travel:
Varies -
Salary:
Competitive -
Responsibilities
Job Description Summary
• Manage the Contract Manufacturer to deliver products that are in compliance to manufacturing process and participation in new product process development.• Manage and provide guidance to Contract Manufacturer in producing consistent product quality meeting product specification.
• Conduct Quality Management System Training and Audits to ensure conformance to Standard.
• Initiate risk assessment, review and approve Process Verification and Validation Plan to ensure consistent Product Quality before change.
Job Description
DUTIES AND RESPONSIBILITIES:
- Coordinate and integrate Quality and Manufacturing activities across BD sites to ensure process alignment for Veritor Product.
- Conduct Quality Training to dry Continuous Improvement
- Conduct Supplier Audit including assessment of new or potential supplier
- Conduct Contract Manufacturer’s Supplier Audit and access effectiveness to mitigation plan in resolving non-compliances.
- Participate in process development and VnV (Verification and Validation) Plan for new product inclusive of Risk Hazard Analysis training to Process Development Team.
- Responsible for communicating and working with Suppliers in regards to Quality issues.
- Collects, interprets and analyzes data and presents to others either orally or in writing.
- Participate on Supplier Improvement project teams.
- Responsible for SAP Transactions as required.
- Responsible for revising and creating Buy Specifications.
- Acts independently, consults with supervisor on unusual situations.
- Work closely with Purchasing on Supplier related activity.
- Travel required for as needed.
MINIMUM QUALIFICATIONS:
- Must have highly developed computer skills in Word, Excel and PowerPoint.
- Working knowledgeable of ISO 13485 and 21 CFR Part 820.
- Problem solving abilities a plus. Able to perform root cause analysis.
- Six Sigma / Lean and Statistics background a plus
- Must be organized and be able to implement programs and projects.
- Ability to communicate and work with all levels of Plant, Division and Supplier Personnel.
KNOWLEDGE AND SKILLS:
- Experience and expertise with quality data analysis and statistics (SPC, Pareto charts, etc.)
- Strong interpersonal skills, demonstrated capability of working on multiple projects at one time.
- Strong oral and written communication skills.
- Strong problem solving skills.
- Demonstrated project management skills.
- Ability to lead without authority
- Experience in transactional six-sigma will be an advantage
EDUCATION AND EXPERIENCE:
- Four year Bachelor’s degree plus 5-7 years of quality engineering experience required.
Primary Work Location
USA MD - Sparks - 7 Loveton CircleAdditional Locations
Work Shift
Success Profile
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.
- Collaborative
- Conceptual
- Creative
- Imaginative
- Problem-solver
- 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.