Johnson & Johnson companies are equal opportunity employers.
SENIOR QUALITY ENGINEER-4310130726
Description
Biosense Webster, Inc (BWI), a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Quality Engineer, to be located in Irwindale, California.
Hi-Tech meets Medical Devices at Biosense Webster! If you want to work with brilliant people in a fast paced environment, help make a huge difference in patient's lives and want to be responsible for providing the most innovative technology in the field of cardiac electrophysiology, then Biosense Webster is the place for you! Our vision and mission are clear - be #1 in rhythm solutions globally and cure AF (Atrial Fibrillation), the most common heart arrhythmia. Our products are used by prominent physicians around the world and help improve thousands of patient's lives. Simply put, we are a highly innovative entrepreneurial company with a truly global and diverse culture, backed with the support structure of the Johnson & Johnson Corporation - quite a winning combination! Our commitment to quality and our Credo have helped us achieve significant milestones as a company.
Biosense Webster is the world leader in the $2.5 billion worldwide electrophysiology market and our company is in the enviable position of being one of the fastest growing businesses within Johnson & Johnson. We have achieved double digit growth consistently over the last decade and aren’t stopping as we look towards the future. Our product portfolio remains strong and further proves we are an innovative leader in cardiac electrophysiology. In order to continue this great growth trajectory, we need to bring on board top talent like you to help fuel our future! Our growth has also enabled a relentless focus on talent development by providing many new opportunities for our employees to expand their knowledge and grow their careers. Our commitment to developing our leaders is unwavering. Our investment in people, technology, and innovation make us one of the best places to work within one of the most admirable corporations in the world.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Senior Quality Engineer participate in New Product Development (NPD) teams and other activities to develop products, design verification tests, process validations and quality processes to ensure compliance with company Quality System policies, procedures, standards (FDA, ISO 13485), other worldwide regulatory agencies, and other applicable standards as they pertain to medical devices. This individual supports production floor activities (IQ/OQ/PQ) and product quality investigations. S/he receives technical guidance on complex problems, but independently determines and develops approaches and solutions. This individual share technical expertise with others and helps develop junior level engineers.
The Senior Quality Engineer primary responsibilities include working in Quality Engineering with other functional groups in support of new product development projects. This individual develops and establishes effective quality control and associated risk management plans. This individual writes, reviews and/or approves process and product validation protocols and reports, equipment qualifications, and engineering change orders. S/he uses statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE). The Senior Quality Engineer directs Failure Mode and Effects Analysis activities. S/he determines sterility, biological and packaging test requirements utilizing appropriate industry or agency standards for new products. S/he ensures that development activities follow design control requirements, product is tested per applicable standards, and product is properly transferred to manufacturing.
The Senior Quality Engineer provides all planning necessary to ensure effective product acceptance. This includes, but is not limited to, equipment and gage requirements, and sampling plans. Software validation experience is a plus. S/he assists in complaint analysis as appropriate. S/he assists Regulatory Affairs in developing submissions for new devices as necessary. This individual participates in design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes. This individual carries out assignments requiring the development of new or improved techniques or procedures. S/he will be involved with change safety and efficacy of products.
The Senior Quality Engineer assesses the feasibility and soundness of proposed engineering evaluation tests, products, or equipment when necessary data are insufficient or confirmation by testing is advisable.
Qualifications
A Bachelor's degree and a minimum of 4 years experience as a Quality Professional in a regulated industry is strongly preferred. Medical Device Industry experience is preferred. An engineering degree or equivalent experience is preferred. A Master's degree is a plus. Excellent knowledge of quality engineering, and verification and validation processes is preferred. GMP experience is required. Superior knowledge of manufacturing systems and applicable regulations (i.e. ISO 13485, FDA's and QSR requirements) is required. The ability to apply project management skills is required. Understanding and demonstrated use of PE /Six Sigma tools and methodologies is preferred.
Strong written and verbal communication skills and the ability to effectively communicate with internal and external personnel at all levels of the organization are required. This position is located in Irwindale, California and may require up to 10% travel.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
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
SENIOR QUALITY ENGINEER-4310130726
Description
Biosense Webster, Inc (BWI), a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Quality Engineer, to be located in Irwindale, California.
Hi-Tech meets Medical Devices at Biosense Webster! If you want to work with brilliant people in a fast paced environment, help make a huge difference in patient's lives and want to be responsible for providing the most innovative technology in the field of cardiac electrophysiology, then Biosense Webster is the place for you! Our vision and mission are clear - be #1 in rhythm solutions globally and cure AF (Atrial Fibrillation), the most common heart arrhythmia. Our products are used by prominent physicians around the world and help improve thousands of patient's lives. Simply put, we are a highly innovative entrepreneurial company with a truly global and diverse culture, backed with the support structure of the Johnson & Johnson Corporation - quite a winning combination! Our commitment to quality and our Credo have helped us achieve significant milestones as a company.
Biosense Webster is the world leader in the $2.5 billion worldwide electrophysiology market and our company is in the enviable position of being one of the fastest growing businesses within Johnson & Johnson. We have achieved double digit growth consistently over the last decade and aren’t stopping as we look towards the future. Our product portfolio remains strong and further proves we are an innovative leader in cardiac electrophysiology. In order to continue this great growth trajectory, we need to bring on board top talent like you to help fuel our future! Our growth has also enabled a relentless focus on talent development by providing many new opportunities for our employees to expand their knowledge and grow their careers. Our commitment to developing our leaders is unwavering. Our investment in people, technology, and innovation make us one of the best places to work within one of the most admirable corporations in the world.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Senior Quality Engineer participate in New Product Development (NPD) teams and other activities to develop products, design verification tests, process validations and quality processes to ensure compliance with company Quality System policies, procedures, standards (FDA, ISO 13485), other worldwide regulatory agencies, and other applicable standards as they pertain to medical devices. This individual supports production floor activities (IQ/OQ/PQ) and product quality investigations. S/he receives technical guidance on complex problems, but independently determines and develops approaches and solutions. This individual share technical expertise with others and helps develop junior level engineers.
The Senior Quality Engineer primary responsibilities include working in Quality Engineering with other functional groups in support of new product development projects. This individual develops and establishes effective quality control and associated risk management plans. This individual writes, reviews and/or approves process and product validation protocols and reports, equipment qualifications, and engineering change orders. S/he uses statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE). The Senior Quality Engineer directs Failure Mode and Effects Analysis activities. S/he determines sterility, biological and packaging test requirements utilizing appropriate industry or agency standards for new products. S/he ensures that development activities follow design control requirements, product is tested per applicable standards, and product is properly transferred to manufacturing.
The Senior Quality Engineer provides all planning necessary to ensure effective product acceptance. This includes, but is not limited to, equipment and gage requirements, and sampling plans. Software validation experience is a plus. S/he assists in complaint analysis as appropriate. S/he assists Regulatory Affairs in developing submissions for new devices as necessary. This individual participates in design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes. This individual carries out assignments requiring the development of new or improved techniques or procedures. S/he will be involved with change safety and efficacy of products.
The Senior Quality Engineer assesses the feasibility and soundness of proposed engineering evaluation tests, products, or equipment when necessary data are insufficient or confirmation by testing is advisable.
Qualifications
A Bachelor's degree and a minimum of 4 years experience as a Quality Professional in a regulated industry is strongly preferred. Medical Device Industry experience is preferred. An engineering degree or equivalent experience is preferred. A Master's degree is a plus. Excellent knowledge of quality engineering, and verification and validation processes is preferred. GMP experience is required. Superior knowledge of manufacturing systems and applicable regulations (i.e. ISO 13485, FDA's and QSR requirements) is required. The ability to apply project management skills is required. Understanding and demonstrated use of PE /Six Sigma tools and methodologies is preferred.
Strong written and verbal communication skills and the ability to effectively communicate with internal and external personnel at all levels of the organization are required. This position is located in Irwindale, California and may require up to 10% travel.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
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