BD is looking to solve product reliability and quality issues by hiring a Senior Quality Manager, Failure Analysis to lead a team in conducting thorough investigations into product failures, identifying root causes, and implementing corrective actions.
Requirements
- Failure Analysis tools, technologies and methodologies
- Quality Engineering, Quality Management, R&D within the medical device industry
- Six Sigma Certification
- Proven expertise in both Microsoft Office Suite and related systems
- Expert understanding of engineering procedures while addressing issues with impact beyond own team based on knowledge of related disciplines
- Expert understanding of related aspects of quality engineering processes and/and or systems
- Expert knowledge of design of experiments, process capability studies, failure mode and effects analysis, statistical process control, industrial statistical methods and Lean Manufacturing
Responsibilities
- Manage project activities with the 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 in order 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.
- 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
Other
- Bachelor's Degree in engineering and 8+ years of medical device industry experience
- Demonstrated track record in management of technical and/or engineering disciplines
- Proven successful project management leadership skills
- Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making
- Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
