Bd
Medical Technology
Sr.QualityEngineer
Neural analysis suggests this role is
optimal for Senior candidates.
“Sr. Quality Engineer at Bd. Skills: Quality Assurance, Design Control, Risk Management, Regulatory Compliance. Serve as Quality Assurance expert for product line. Own Design Control, Document Control, and QA processes”
What You'll Achieve.
Protect patient safety; Protect business risk; Drive innovation; Ensure compliance; Demonstrate continuous improvement
Industry & Context.
Problem-solving skills; Root cause analysis
What They're Looking For.
Must Have
Bachelor's Degree in Engineering and 4 Quality Engineering experience in a regulated environment, Master's Degree and 2 years of Quality Engineering experience in a regulated environment, Good questioning and problem-solving skills, Detail oriented and ability to organize large amounts of work and data, Good documentation practices, Plans effectively and team oriented, Regulatory knowledge and experience including but not limited to FDA, MDSAP, PMDA, CFDA, Demonstrated experience working with international suppliers/manufacturers as it relates to product quality and reliability, Demonstrated history of successfully interpreting regulations, and procedures, Demonstrated skill in statistical analysis and applied statistical methodologies, Knowledge and understanding of IEC 60601 standards
Nice to Have
Capital system experience (Electro-mechanical), ASQ Certification
What You'll Do.
Serve as Quality Assurance expert for product line
Collaborate with contract manufacturers and internal plants to
Monitor complaint trends
Identify performance drift
Execute swift corrective actions
Serve as go-to resource for cross-functional teams
Serve as Quality Representative on Project Teams
Ensure Design Control principles are woven into every
Provide QA leadership for Project Teams and the
and approve critical Quality System Documents
Create and approve CAPAs
Create and approve Audit reports
Create and approve Design History Files
and approve Protocols for Process and
and approve Protocols for Stability studies
and approve Protocols for Software Validation
Create comprehensive Risk Assessments
Provide supervision to technicians and engineers
Analyze process and product non-conformances
Implement comprehensive corrective and preventive action plans
Conduct Internal Quality System Audits
Conduct Supplier Quality System Audits
Maintain active membership in trade and professional organizations
Perform thorough Complaint reviews
Perform thorough Complaint investigations
Monitor and trend Quality Indicators
Work seamlessly with manufacturing facilities and other Division
Serve as Independent QA Reviewer
Serve as Chairperson for Design Reviews
How You'll Work.
Team & Collaboration
Cross-functional teams; Project Teams; Manufacturing facilities; Other Division Facilities
Full Job Description
**We are the people who give possibilities purpose** BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. # Job Description Join our team as a Senior Design Quality Engineer where you'll be the guardian of quality for our critical product family, directly protecting patient safety and business risk while driving innovation in medical device development! You'll work at the intersection of innovation and compliance, ensuring every change we make is robust, validated, and protects both our patients and our business. **Responsibilities:** * **Quality Leadership Across the Product Lifecycle:** Serve as the Quality Assurance expert for your entire product line, owning Design Control, Document Control, and QA processes from concept to commercialization * **Strategic Partnership:** Collaborate with contract manufacturers and internal plants to seamlessly implement changes while maintaining the highest quality standards * **Proactive Risk Management:** Monitor complaint trends like a detective, identifying performance drift before it becomes a problem and executing swift corrective actions * **Subject Matter Authority:** Be the go-to resource for cross-functional teams in Engineering, Operations, and supplier management**** * **C****hampion Design Control Excellence:** Serve as the Quality Representative on Project Teams, ensuring Design Control principles are woven into every Product and Process Change and New Product Development initiative * **Lead Quality Initiatives:** Provide QA leadership for Project Teams and the Quality Department. * **Master Documentation:** Build, review, and approve critical Quality System Documents includ
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