Johnson & Johnson companies are equal opportunity employers.
Quality Systems & Compliance Manager-0440140514
Description
Ethicon, a member of the Johnson & Johnson Family of Companies, is recruiting for a Quality Systems & Compliance Manager to be located in Athens, GA.
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 Quality Systems & Compliance Manager ensures the Quality Management System is maintained in a state of readiness and compliance to applicable regulations and directives such as 21CFR820, ISO13485, Medical Device Directive MDD, ANVISA and applicable regulatory requirements. Utilizes a thorough familiarity with the regulations and standards applicable, provide compliance education for the facility in support of overall educational strategies. Ensures that the Quality System is regularly audited/reviewed and that changes needed are implemented. Conducts and supports individual and team audits to determine compliance to regulations/standards. Report and present results/recommendations to management. Leads the facility in achieving positive external inspection results. Drive the development, implementation, and maintenance of the Inspection Readiness program. Coordinates and reports inspection schedules. Partners with key individuals and teams within the facility to provide leadership and compliance expertise with a focus of achieving compliance with solutions that are not complex or burdensome to the organization. Maintains close interaction and network with peers at Ethicon sites to address quality related issues. Participates in the development of procedures, specifications, cost control planning, self-inspection methods, and Quality systems. Enforces, implements, and follows up on procedures and specifications. Participates with Operations in developing, coordinating and implementing projects for improvement of quality systems. Provides feedback to operations on problems related to quality and/or compliance. Supports/initiates investigations of non-conformances.
Qualifications
To be considered for the role a minimum of a Bachelor’s degree in a Technical or Science field is required. Three years’ experience in medical device manufacturing industry with a strong knowledge of QSR, ISO 13485 and other applicable regulations and standards. Experience with Combination and Class III devices or drugs is preferred. Three to five years of related experience in a World Class Manufacturing environment. One to three years of supervisory experience. ASQ Certified Quality Auditor (CQA) or ISO Certified Lead Auditor preferred. Required proven leadership, teamwork, initiative, and assertiveness skills; demonstrated collaboration and influencing skills. Strong Project Management skills. Strong computer skills and use of software application(s) (MS Windows, MS Office: Excel, PowerPoint and Word, others) are required. Strong written and oral communication skills. The ability to travel up to 15%, both domestic and internationally will be required.
BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W: LI NA
J2W:BIO
J2W:NSJ
J2W:MZ
J2W:DICE
Primary Location:North America-United States-Georgia-Athens
Organization: Ethicon Inc. (6045)
Job Function: Compliance
Travel:Yes, 10 % 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.
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 Systems & Compliance Manager-0440140514
Description
Ethicon, a member of the Johnson & Johnson Family of Companies, is recruiting for a Quality Systems & Compliance Manager to be located in Athens, GA.
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 Quality Systems & Compliance Manager ensures the Quality Management System is maintained in a state of readiness and compliance to applicable regulations and directives such as 21CFR820, ISO13485, Medical Device Directive MDD, ANVISA and applicable regulatory requirements. Utilizes a thorough familiarity with the regulations and standards applicable, provide compliance education for the facility in support of overall educational strategies. Ensures that the Quality System is regularly audited/reviewed and that changes needed are implemented. Conducts and supports individual and team audits to determine compliance to regulations/standards. Report and present results/recommendations to management. Leads the facility in achieving positive external inspection results. Drive the development, implementation, and maintenance of the Inspection Readiness program. Coordinates and reports inspection schedules. Partners with key individuals and teams within the facility to provide leadership and compliance expertise with a focus of achieving compliance with solutions that are not complex or burdensome to the organization. Maintains close interaction and network with peers at Ethicon sites to address quality related issues. Participates in the development of procedures, specifications, cost control planning, self-inspection methods, and Quality systems. Enforces, implements, and follows up on procedures and specifications. Participates with Operations in developing, coordinating and implementing projects for improvement of quality systems. Provides feedback to operations on problems related to quality and/or compliance. Supports/initiates investigations of non-conformances.
Qualifications
To be considered for the role a minimum of a Bachelor’s degree in a Technical or Science field is required. Three years’ experience in medical device manufacturing industry with a strong knowledge of QSR, ISO 13485 and other applicable regulations and standards. Experience with Combination and Class III devices or drugs is preferred. Three to five years of related experience in a World Class Manufacturing environment. One to three years of supervisory experience. ASQ Certified Quality Auditor (CQA) or ISO Certified Lead Auditor preferred. Required proven leadership, teamwork, initiative, and assertiveness skills; demonstrated collaboration and influencing skills. Strong Project Management skills. Strong computer skills and use of software application(s) (MS Windows, MS Office: Excel, PowerPoint and Word, others) are required. Strong written and oral communication skills. The ability to travel up to 15%, both domestic and internationally will be required.
BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W: LI NA
J2W:BIO
J2W:NSJ
J2W:MZ
J2W:DICE
Primary Location:North America-United States-Georgia-Athens
Organization: Ethicon Inc. (6045)
Job Function: Compliance
Travel:Yes, 10 % 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.
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