HireDiversity

Fremont, CA, US

Principal Quality Systems Engineer-9445120711

Description

Cordis, a Member of Johnson & Johnson's Family of Companies is recruiting for a Principal Quality Systems Engineer, located in Fremont, CA and or Miami Lakes, FL.

Cordis is a recognized leader in providing physicians with breakthrough treatment solutions for peripheral vascular disease, a leader in circulatory disease management, interventional cardiology, radiology and electrophysiology products for circulatory disease management.

Over the last 50 years, a deep understanding of the medical marketplace, unrivaled concern for the needs of patients, and high impact technological innovation have made Cordis a strong developer of breakthrough products for interventional medicine, minimally invasive computer-based imaging and electrophysiology. Today, Cordis employees from around the world share a strong commitment to continue our company's groundbreaking work.

The Principal Quality Systems Engineer will be responsible for providing guidance and concurrence for all Quality System related activities for the area of responsibility. They will escalate when necessary issues as a result of prioritization or inactivity. Provide guidance and works directly with document owners and functional area management for completeness, compliance, and adherence to documentation/change/records management procedures and processes. Reviews and provide concurrence on documentation/change/records management procedures and processes. Participate as a key member in both internal and external audits. They can be assigned as the system owner for documentation/change/records and serves as backup to Global System Manager. Serves as participant in Management review (as needed). Responsible for providing performance metrics for review meetings and dashboards. Oversee overall compliance to all documentation/change/records management related activities for their area of responsibility. Applies intensive and diversified knowledge of engineering principles and practices in broad areas of assignments and related fields. Analyzes reports and returned products and recommends corrective action. Fully competent engineer in all conventional aspects of the subject matter, functional area, and assignments. Devises new approaches to problems encountered. Independently performs all assignments with instructions as to the general results expected. Plans, schedules, conducts, and coordinates detailed phases of engineering work in a total project of complex scope. May technically supervise, coordinate and review the work of a small staff of engineers and technicians, estimates manpower needs and schedules and assigns work to meet completion date, or, as individual researcher or staff specialist may be assisted on projects by other engineers or technicians.

Qualifications


A BA/BS in Engineering, Science or related field of study with a minimum of six or more years of related experience and/or training. Experience in the medical-device/ pharmaceutical industries is preferred.

A Process Excellence Black Belt Certification or Green Belt certified with a plan for Black Belt with demonstrated problem-solving skills is preferred. A passionate and tenacious pursuit of quality improvement is required. Demonstrated project management experience with strong results orientation is preferred. Demonstrated ability to manage (upward/downward, strategically/tactical) and utilized conflict management skills to achieve results is preferred. Strong communication and influencing skills are preferred. Ability to participate in multi-level, formal presentation environment is preferred. Knowledge of regulatory requirements (QSR and ISO) is required. Demonstrated ability with external auditing bodies is preferred. Working knowledge of GMP/ISO/FDA requirements is required. A record of continuous education and/or training is preferred. Ability to use PC's and associated software is required. Ability to effectively deal with and negotiate with representatives of various government and auditing agencies is preferred. Management/Leadership experience is preferred. Quality Systems experience is required. Experience with CAPA, Management Review and Non-Conformance is preferred. Travel of 10% is required.

Primary Location:North America-United States-California-Fremont
Organization: Cordis Corporation (6017)
Relocation: Eligible
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