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Senior Supplier Quality Engineer-2378140108
Description
Ethicon Endo- Surgery, Inc., a member of Johnson & Johnson's Family of Companies, is currently recruiting for a/n Senior Quality Engineer, Supplier located in Cincinnati, OH, Juarez, MX, Albuquerque, NM or Puerto Rico.
The Global Surgery Group is comprised of the following businesses within Johnson & Johnson: Ethicon Surgical Care, Ethicon Energy, Ethicon Biosurgery, Acclarent, Biosense Webster, Cordis, Advanced Sterilization Products, Sedasys, Mentor and Sterilmed. With annual sales of $11 billion, the Global Surgery Group is the world’s largest, most innovative surgical company. The strength of the Global Surgery Group is illustrated by the fact that more than 80% of our sales come from businesses with #1 or #2 global market share positions. We serve customers around the world, with about 60% of our sales generated outside the U.S., including a fast-growing presence in emerging markets. The Global Surgery Group is committed to innovation, with about 30% of our sales coming from products introduced in the past five years.
The Ethicon Surgical Care business offers a broad range of products, platforms and technologies—including sutures, surgical staplers, clip appliers, trocars and synthetic mesh devices—that are used in a wide variety of minimally invasive and open surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women’s health conditions, hernias, cancer and obesity. The Ethicon Surgical Care business combines products and services of two market-leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and effectiveness of open surgery. Ethicon Endo-Surgery, Inc. was created 20 years ago in Cincinnati, Ohio, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today.
The Supplier Quality Engineers are responsible for support and leadership of Quality Engineering activities in of New Product Development, Ongoing Manufacturing - including resolution of non-conformances (root cause & corrective action), CAPA, Quality System and process improvement activities.
The Senior Quality Engineer will provide leadership in design & implementation of world-class quality engineering to support entire product life cycle with focus on quality engineering activities such as reliability, root cause/corrective action risk management, analytics/statistical techniques, requirements management, verification & validation, and design control across the lifecycle of the product. Activities include driving correction, corrective action, prevention, detection of defects at earliest phase of product design, continuous improvement & customer satisfaction. Provide leadership, technical expertise to ensure conformance to ISO, FDA (Food & Drug Administration) & MDD (Medical Devices Directive) based quality systems. Provide review and approval for the release of new products ensuring quality requirements are met Provide leadership & support to J&J process excellence initiatives including Six-sigma, design excellence & lean thinking. Direct development & consistent application of quality policies & procedures in product design & development, secondary development & transfer operations. Act as technical liaison, as needed, between product development, manufacturing, external manufacturers & suppliers. Candidates should have strong analytical problem solving skills and sound statistical application in areas such as DOE, sampling techniques, regression, reliability, FMEA, hypothesis testing, etc.
Qualifications
A Bachelor's degree in Engineering- Mechanical, Electrical, Industrial - is preferred. CQE, CRE, CQA - Ratings, preferred. 5 or more years related work experience, in a medical device area, or equivalent is required. Experience in auditing for compliance to ISO or GMP standards, CRE (Reliability Engineer Certification), CQA (Quality Auditor Certification) is preferred.
It is preferred to have experience with Advanced Quality Systems (AQS), Process Excellence/Lean/Six Sigma, Team interpersonal: feedback, negotiating, and training. Experience with Reliability & Quality Engineering, Quality Assertiveness, Analytical & Creative thinking, Project Management skills in order to support multiple projects simultaneously, problem-solving & priority setting, organizational & integral - synthesize information from a variety of sources are all preferred skills. This individual must be capable to understand new concepts quickly, research and maintain ongoing learning of industry and regulations. The candidate should have knowledge of Regulatory compliance knowledge: GMP, MDD (Medical Devices Directive), 510K (Pre-market Notification), PMA (Pre-market Approval), and Government, trade association, industry & medical publications. This position may require up to 25% 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-Ohio-Cincinnati
Other Locations:North America-United States-New Mexico-Albuquerque, North America-United States-Puerto Rico
Organization: Ethicon Endo Surgery Inc (6041)
Job: Quality (Eng)
Travel:Yes, 25 % of the Time
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.
Senior Supplier Quality Engineer-2378140108
Description
Ethicon Endo- Surgery, Inc., a member of Johnson & Johnson's Family of Companies, is currently recruiting for a/n Senior Quality Engineer, Supplier located in Cincinnati, OH, Juarez, MX, Albuquerque, NM or Puerto Rico.
The Global Surgery Group is comprised of the following businesses within Johnson & Johnson: Ethicon Surgical Care, Ethicon Energy, Ethicon Biosurgery, Acclarent, Biosense Webster, Cordis, Advanced Sterilization Products, Sedasys, Mentor and Sterilmed. With annual sales of $11 billion, the Global Surgery Group is the world’s largest, most innovative surgical company. The strength of the Global Surgery Group is illustrated by the fact that more than 80% of our sales come from businesses with #1 or #2 global market share positions. We serve customers around the world, with about 60% of our sales generated outside the U.S., including a fast-growing presence in emerging markets. The Global Surgery Group is committed to innovation, with about 30% of our sales coming from products introduced in the past five years.
The Ethicon Surgical Care business offers a broad range of products, platforms and technologies—including sutures, surgical staplers, clip appliers, trocars and synthetic mesh devices—that are used in a wide variety of minimally invasive and open surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women’s health conditions, hernias, cancer and obesity. The Ethicon Surgical Care business combines products and services of two market-leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and effectiveness of open surgery. Ethicon Endo-Surgery, Inc. was created 20 years ago in Cincinnati, Ohio, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today.
The Supplier Quality Engineers are responsible for support and leadership of Quality Engineering activities in of New Product Development, Ongoing Manufacturing - including resolution of non-conformances (root cause & corrective action), CAPA, Quality System and process improvement activities.
The Senior Quality Engineer will provide leadership in design & implementation of world-class quality engineering to support entire product life cycle with focus on quality engineering activities such as reliability, root cause/corrective action risk management, analytics/statistical techniques, requirements management, verification & validation, and design control across the lifecycle of the product. Activities include driving correction, corrective action, prevention, detection of defects at earliest phase of product design, continuous improvement & customer satisfaction. Provide leadership, technical expertise to ensure conformance to ISO, FDA (Food & Drug Administration) & MDD (Medical Devices Directive) based quality systems. Provide review and approval for the release of new products ensuring quality requirements are met Provide leadership & support to J&J process excellence initiatives including Six-sigma, design excellence & lean thinking. Direct development & consistent application of quality policies & procedures in product design & development, secondary development & transfer operations. Act as technical liaison, as needed, between product development, manufacturing, external manufacturers & suppliers. Candidates should have strong analytical problem solving skills and sound statistical application in areas such as DOE, sampling techniques, regression, reliability, FMEA, hypothesis testing, etc.
Qualifications
A Bachelor's degree in Engineering- Mechanical, Electrical, Industrial - is preferred. CQE, CRE, CQA - Ratings, preferred. 5 or more years related work experience, in a medical device area, or equivalent is required. Experience in auditing for compliance to ISO or GMP standards, CRE (Reliability Engineer Certification), CQA (Quality Auditor Certification) is preferred.
It is preferred to have experience with Advanced Quality Systems (AQS), Process Excellence/Lean/Six Sigma, Team interpersonal: feedback, negotiating, and training. Experience with Reliability & Quality Engineering, Quality Assertiveness, Analytical & Creative thinking, Project Management skills in order to support multiple projects simultaneously, problem-solving & priority setting, organizational & integral - synthesize information from a variety of sources are all preferred skills. This individual must be capable to understand new concepts quickly, research and maintain ongoing learning of industry and regulations. The candidate should have knowledge of Regulatory compliance knowledge: GMP, MDD (Medical Devices Directive), 510K (Pre-market Notification), PMA (Pre-market Approval), and Government, trade association, industry & medical publications. This position may require up to 25% 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-Ohio-Cincinnati
Other Locations:North America-United States-New Mexico-Albuquerque, North America-United States-Puerto Rico
Organization: Ethicon Endo Surgery Inc (6041)
Job: Quality (Eng)
Travel:Yes, 25 % of the Time
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.