Senior Quality Engineering Leader, Failure Analysis

Regulatory Jobs; Irvine (CA); On-site; USD 165,000 - 263,000; Full time

Benefits offered by this job

Six Sigma training

Job summary

BD, a global medical technology leader, is seeking a Senior Quality Manager for Failure Analysis in Irvine, CA. Lead a team of engineers and technicians to investigate product failures, identify root causes, and implement corrective actions ensuring reliability and quality across medical devices.

Responsibilities include developing failure analysis tools, CAPA program leadership, and coordinating cross-functional efforts with a focus on Six Sigma/LEAN methods and regulatory compliance (FDA, GMP,

Qualifications

• Bachelor's Degree in engineering.
• 8+ years of medical device industry experience in Failure Analysis tools, technologies and methodologies, complaint investigation and handling, strong data analytical experience
• Quality Engineering, Quality Management, R&D
• Demonstrated track record in management of technical and/or engineering disciplines

Responsibilities

• Manage project activities with accountability for successful completion of all deliverables to the business and develop project plans, schedule, scope and objectives while using engineering methods (e.g., SIX Sigma and LEAN methods), employing technical design skills to re‑design/design on new products and/or processes.
• Develop failure analysis tools and processes for ongoing root cause analysis, focused on proactive actions to improve the overall quality of our products.
• Manage and/or oversee the work of assigned team within own function and/or cross functional project teams and may have some budgetary responsibilities.
• Develop a robust talent development plan in alignment with functional growth strategies of the department Provide technical guidance to cross-functional and/or departmental groups to develop and provide design recommendations that integrate into component(s) or product(s) with moderate complexity
• Lead the implementation of CAPA program including training, approvals, and system effectiveness
• Interact with subordinate production supervisors, customers, and/or functional peer group managers, normally involving matters between functional areas, other company divisions or units, or customers and the company; lead a cooperative effort among members of a project team Participate and present at meetings with internal and external representatives
• Resolve operational and scheduling issues
• Other incidental duties

Skills

Six Sigma Certification

Project management

Quality engineering

Data analysis

Leadership

Regulatory knowledge FDA GMP ISO

Education

Bachelor's Degree in engineering

Tools

Microsoft Office Suite

Job description

BD, a global medical technology leader, is seeking a Senior Quality Manager for Failure Analysis in Irvine, CA. Lead a team of engineers and technicians to investigate product failures, identify root causes, and implement corrective actions ensuring reliability and quality across medical devices.

Responsibilities include developing failure analysis tools, CAPA program leadership, and coordinating cross-functional efforts with a focus on Six Sigma/LEAN methods and regulatory compliance (FDA, GMP,