Johnson & Johnson companies are equal opportunity employers.
SENIOR QUALITY ENGINEER-1088140522
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 participates in New Product Development (NPD) 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 shares technical expertise with others and helps to 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 minimum of a Bachelor’s degree in Mechanical, Aerospace, Biomedical or related Engineering field is required. A minimum of 4 – 6 years of quality, manufacturing, or research and development experience in a medical device or other regulated industry is required. A Master’s degree is preferred. Experience in the medical device industry – catheter manufacturing/electrophysiology industry is preferred. American Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools is desirable. Knowledge of GD&T (Geometric Dimensioning and Tolerancing) is preferred. The successful candidate should have the ability to implement Quality standards. The successful candidate should have knowledge of or education in Quality and operations systems and processes, including GMP and QSR requirements for medical devices or other regulated products. The successful candidate should have experience or knowledge of Quality Engineering, design control, and verification and validation (V&V) tools and methodologies, including a strong understanding of risk management processes. The successful candidate should have the ability to apply project management skills to fulfill new product development requirements. Strong problem solving skills are required. Strong verbal and written communication skills and ability to effectively communicate with internal and external personnel are required. The position is located in Irwindale, CA and may require <20% travel.
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
SENIOR QUALITY ENGINEER-1088140522
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 participates in New Product Development (NPD) 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 shares technical expertise with others and helps to 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 minimum of a Bachelor’s degree in Mechanical, Aerospace, Biomedical or related Engineering field is required. A minimum of 4 – 6 years of quality, manufacturing, or research and development experience in a medical device or other regulated industry is required. A Master’s degree is preferred. Experience in the medical device industry – catheter manufacturing/electrophysiology industry is preferred. American Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools is desirable. Knowledge of GD&T (Geometric Dimensioning and Tolerancing) is preferred. The successful candidate should have the ability to implement Quality standards. The successful candidate should have knowledge of or education in Quality and operations systems and processes, including GMP and QSR requirements for medical devices or other regulated products. The successful candidate should have experience or knowledge of Quality Engineering, design control, and verification and validation (V&V) tools and methodologies, including a strong understanding of risk management processes. The successful candidate should have the ability to apply project management skills to fulfill new product development requirements. Strong problem solving skills are required. Strong verbal and written communication skills and ability to effectively communicate with internal and external personnel are required. The position is located in Irwindale, CA and may require <20% travel.
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