Johnson & Johnson companies are equal opportunity employers.
QUALITY ENGINEER I-8304140409
Description
Biosense Webster, Inc., is recognized worldwide as an industry leader in endocardial diagnostics and therapy. Guided by the needs of electrophysiologists and cardiologists, the company has pioneered innovative technological advancements ranging from the first deflectable tip catheter to today's most sophisticated three-dimensional cardiac mapping and navigation systems. Biosense Webster, Inc., combines leading-edge technology with a tradition of quality and responsiveness while partnering with the physician to optimize patient outcomes. Bionsense Webster, Inc., a member of the Johnson & Johnson Family of Companies, is recruiting for a Quality Engineer I to support the BWI franchise located in Irwindale, CA
The Quality Engineer I under general supervision, receives instructions about required tasks and results expected. The Quality Engineer I will support senior staff to ensure compliance with the company’s Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, Johnson & Johnson Environmental Practices, and applicable standards as pertains to medical devices. Support quality operations production floor functions, design activities, and investigations. The Quality Engineer I work is usually well defined and is checked for progress and reviewed for accuracy upon completion.
The Quality Engineer I will assist in a supporting role on sustaining quality operations and new product development projects. The Quality Engineer will assist in the development of effective quality control and associated risk management plans. The Quality Engineer will write process and product validation protocols and reports, equipment qualifications, engineering change orders. The Quality Engineer will use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE), assist in Failure Mode and Effects Analysis activities for both Process and Design FMEA’s. The Quality Engineer will help to ensure that development activities follow design control requirements, product is tested per applicable standards, essential requirements are met, and product is properly transferred to manufacturing. The Quality Engineer I will assist in planning necessary to ensure effective product acceptance. This includes, but is not limited to, inspection instructions, equipment and gage requirements, and sampling plans. The Quality Engineer 1 will participate in MRB review of nonconforming product and recommend disposition and corrective action.
The Quality Engineer I will support and coordinate the NCR and/or On Hold Notification management process. The Quality Engineer I will initiate and investigate Corrective and Preventative Actions (CAPA) as appropriate. The Quality Engineer I will assist in complaint analysis as appropriate. The Quality Engineer I will require moderate use of judgment on details of work and in making selections and adaptations of engineering alternatives. The Quality Engineer I will supervise screening of assignments for unusual or difficult problems and review techniques and procedures to be applied on non-routine work. The Quality Engineer I will receive general direction on new aspects of assignments. The Quality Engineer I will perform work which involves conventional types of plans, investigations, surveys, structures, or equipment with relatively few complex features for which there are precedents. The Quality Engineer I will be responsible for communicating business related issues or opportunities to next management level. The Quality Engineer I will be responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition. The Quality Engineer I will be responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures. The Quality Engineer will performs other duties assigned as needed.
Qualifications
A minimum of a Bachelor’s degree in Engineering or a related field of study plus 0 – 2 years work experience required. American Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools is desirable. Candidate should have the ability to develop and implement Quality standards. Candidate should have some knowledge of or education in Quality and operations systems and processes, including GMP and QSR requirements for medical devices. Candidate should have some knowledge of or education in Quality Engineering, design control, and verification and validation (V&V) tools and methodologies. Some knowledge of or education in geometric dimensioning and tolerancing (GD&T) is desirable. Candidate should have the ability to apply project management skills to fulfill new product development requirements. Candidate should have problem solving skills. Candidate must have excellent verbal and written communication skills and the ability to effectively communicate with internal and external personnel.
BE VITAL in your career, Be seen for the talent you bring to work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W:LI NA
Primary Location:North America-United States-California-Irwindale
Organization: Biosense Webster Inc. (6010)
Job Function: Quality (Eng)
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement
QUALITY ENGINEER I-8304140409
Description
Biosense Webster, Inc., is recognized worldwide as an industry leader in endocardial diagnostics and therapy. Guided by the needs of electrophysiologists and cardiologists, the company has pioneered innovative technological advancements ranging from the first deflectable tip catheter to today's most sophisticated three-dimensional cardiac mapping and navigation systems. Biosense Webster, Inc., combines leading-edge technology with a tradition of quality and responsiveness while partnering with the physician to optimize patient outcomes. Bionsense Webster, Inc., a member of the Johnson & Johnson Family of Companies, is recruiting for a Quality Engineer I to support the BWI franchise located in Irwindale, CA
The Quality Engineer I under general supervision, receives instructions about required tasks and results expected. The Quality Engineer I will support senior staff to ensure compliance with the company’s Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, Johnson & Johnson Environmental Practices, and applicable standards as pertains to medical devices. Support quality operations production floor functions, design activities, and investigations. The Quality Engineer I work is usually well defined and is checked for progress and reviewed for accuracy upon completion.
The Quality Engineer I will assist in a supporting role on sustaining quality operations and new product development projects. The Quality Engineer will assist in the development of effective quality control and associated risk management plans. The Quality Engineer will write process and product validation protocols and reports, equipment qualifications, engineering change orders. The Quality Engineer will use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE), assist in Failure Mode and Effects Analysis activities for both Process and Design FMEA’s. The Quality Engineer will help to ensure that development activities follow design control requirements, product is tested per applicable standards, essential requirements are met, and product is properly transferred to manufacturing. The Quality Engineer I will assist in planning necessary to ensure effective product acceptance. This includes, but is not limited to, inspection instructions, equipment and gage requirements, and sampling plans. The Quality Engineer 1 will participate in MRB review of nonconforming product and recommend disposition and corrective action.
The Quality Engineer I will support and coordinate the NCR and/or On Hold Notification management process. The Quality Engineer I will initiate and investigate Corrective and Preventative Actions (CAPA) as appropriate. The Quality Engineer I will assist in complaint analysis as appropriate. The Quality Engineer I will require moderate use of judgment on details of work and in making selections and adaptations of engineering alternatives. The Quality Engineer I will supervise screening of assignments for unusual or difficult problems and review techniques and procedures to be applied on non-routine work. The Quality Engineer I will receive general direction on new aspects of assignments. The Quality Engineer I will perform work which involves conventional types of plans, investigations, surveys, structures, or equipment with relatively few complex features for which there are precedents. The Quality Engineer I will be responsible for communicating business related issues or opportunities to next management level. The Quality Engineer I will be responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition. The Quality Engineer I will be responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures. The Quality Engineer will performs other duties assigned as needed.
Qualifications
A minimum of a Bachelor’s degree in Engineering or a related field of study plus 0 – 2 years work experience required. American Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools is desirable. Candidate should have the ability to develop and implement Quality standards. Candidate should have some knowledge of or education in Quality and operations systems and processes, including GMP and QSR requirements for medical devices. Candidate should have some knowledge of or education in Quality Engineering, design control, and verification and validation (V&V) tools and methodologies. Some knowledge of or education in geometric dimensioning and tolerancing (GD&T) is desirable. Candidate should have the ability to apply project management skills to fulfill new product development requirements. Candidate should have problem solving skills. Candidate must have excellent verbal and written communication skills and the ability to effectively communicate with internal and external personnel.
BE VITAL in your career, Be seen for the talent you bring to work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W:LI NA
Primary Location:North America-United States-California-Irwindale
Organization: Biosense Webster Inc. (6010)
Job Function: Quality (Eng)
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement