Senior Compliance Engineer Job
Company Name:
Ethicon Inc. (6045)
Cornelia, GA, US
Johnson & Johnson companies are equal opportunity employers.
Senior Compliance Engineer
Description
Ethicon, Inc., a member of the Medical Devices & Diagnostics Global Services, L.L.C., Global Supply Chain organization, within Johnson & Johnson's Family of Companies, is recruiting for a Senior Quality Compliance Engineer, to be located in Cornelia, GA.
Medical Devices & Diagnostics (MD&D) Global Services, L.L.C., represents more than 60 manufacturing sites and 26,000 employees who plan, source, manufacture and deliver high-quality and cost-effective medical products to our customers around the globe each day. Work of the MD&D Supply Chain supports a multitude of product platforms, new products and delivery systems that are used in a wide range of procedures throughout the healthcare industry, including interventional cardiology, electrophysiology, minimally invasive surgery, hospital sterilization, clinical laboratory testing, diabetes management, joint replacement surgery and vision care.
The Senior Quality Compliance Engineer ensures the continuous implementation/improvement of Quality Compliance efforts. This individual provides objective, independent review of the quality compliance risk by evaluating and auditing Quality Systems and taking appropriate preventive/corrective actions to ensure that Quality Systems meet the business and regulatory requirements.
The Senior Quality Compliance Engineer will be responsible for establishing and maintaining programs for the ongoing monitoring and improvement of the effectiveness of the Quality System. The Senior Quality Compliance Engineer will also be responsible for the creation, deployment, and maintenance of the internal audit schedule as well as status updates and reporting on resource or schedule adherence challenges.
The Senior Quality Compliance Engineer ensures that audit procedures align with MD&D expectations. Performs required audits in accordance with defined procedures and the master schedule; identifies and performs for cause audits. Ensures proper reporting, response review and approvals, communication of issues, and use of tracking and trending tools. Escalates key issues to upper management as appropriate. Trends, reports and presents any corrective action results/recommendations to facility management. Provides routine communication and updates to site and franchise organizational management regarding compliance trends and initiatives. Works effectively with the other site compliance engineers/ specialists to ensure consistent systems. Drives Compliance improvements, which result from internal audits, Quality Board Issues and other system indicators and provides leadership to identify and drive closure of potential compliance gaps. Establishes and maintains regulatory inspection readiness plans at the manufacturing site. Coordinates logistical planning for regulatory inspections with agencies such as the FDA, and ISO. Serves as a representative during such audits, hosting, facilitating communications, facility touring, information requests, and corrective action and/or remediation plans as necessary. Develops and maintains key quality and compliance performance metrics. Participates in developing and presenting departmental materials for Management Reviews. Promotes a culture of Regulatory Compliance and Risk Management throughout the organization. Coaches and guides Quality System Auditors and supports staff as required to ensure appropriate control systems are in place and continually optimized to meet changing regulatory, corporate and industry standards. Maintains current knowledge of regulatory changes through industry publications, seminars, professional affiliation and industry meetings. Supports departmental and franchise objectives while adhering to the values of the Johnson & Johnson Credo and local safety and environmental policy and procedure.
Qualifications
A Bachelor's degree and a minimum of four (4) years of professional work experience within a quality or compliance audit environment is required. A degree in Engineering, a Life Science or a related technical discipline is preferred. A Master's degree is highly desirable, preferably an MBA. Experience working in a Medical Device / Pharmaceutical / Biologics manufacturing environment is required. Certification as a Lead Auditor is required. ASQ CQA, CQE, CBA or Qualified ISO Lead Assessor certification is preferred. A minimum of 2 years of experience conducting and/or leading regulatory assessments in a global context, in a regulated environment is preferred. Prior experience supporting External Regulatory and/or Notified Body Inspections (e.g. FDA, BSi etc) is preferred. Strong communication, organization, negotiation and interpersonal skills are required. Strong statistical and analytical problem solving skills are required. The ability to collaborate with all levels of management across multiple sites and functions is required.
This position will be located in Cornelia, GA 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-Georgia-Cornelia
Organization:
Ethicon Inc. (6045)
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 SupplementEstimated Salary: $20 to $28 per hour based on qualifications.
Ethicon Inc. (6045)
Cornelia, GA, US
Johnson & Johnson companies are equal opportunity employers.
Senior Compliance Engineer
Description
Ethicon, Inc., a member of the Medical Devices & Diagnostics Global Services, L.L.C., Global Supply Chain organization, within Johnson & Johnson's Family of Companies, is recruiting for a Senior Quality Compliance Engineer, to be located in Cornelia, GA.
Medical Devices & Diagnostics (MD&D) Global Services, L.L.C., represents more than 60 manufacturing sites and 26,000 employees who plan, source, manufacture and deliver high-quality and cost-effective medical products to our customers around the globe each day. Work of the MD&D Supply Chain supports a multitude of product platforms, new products and delivery systems that are used in a wide range of procedures throughout the healthcare industry, including interventional cardiology, electrophysiology, minimally invasive surgery, hospital sterilization, clinical laboratory testing, diabetes management, joint replacement surgery and vision care.
The Senior Quality Compliance Engineer ensures the continuous implementation/improvement of Quality Compliance efforts. This individual provides objective, independent review of the quality compliance risk by evaluating and auditing Quality Systems and taking appropriate preventive/corrective actions to ensure that Quality Systems meet the business and regulatory requirements.
The Senior Quality Compliance Engineer will be responsible for establishing and maintaining programs for the ongoing monitoring and improvement of the effectiveness of the Quality System. The Senior Quality Compliance Engineer will also be responsible for the creation, deployment, and maintenance of the internal audit schedule as well as status updates and reporting on resource or schedule adherence challenges.
The Senior Quality Compliance Engineer ensures that audit procedures align with MD&D expectations. Performs required audits in accordance with defined procedures and the master schedule; identifies and performs for cause audits. Ensures proper reporting, response review and approvals, communication of issues, and use of tracking and trending tools. Escalates key issues to upper management as appropriate. Trends, reports and presents any corrective action results/recommendations to facility management. Provides routine communication and updates to site and franchise organizational management regarding compliance trends and initiatives. Works effectively with the other site compliance engineers/ specialists to ensure consistent systems. Drives Compliance improvements, which result from internal audits, Quality Board Issues and other system indicators and provides leadership to identify and drive closure of potential compliance gaps. Establishes and maintains regulatory inspection readiness plans at the manufacturing site. Coordinates logistical planning for regulatory inspections with agencies such as the FDA, and ISO. Serves as a representative during such audits, hosting, facilitating communications, facility touring, information requests, and corrective action and/or remediation plans as necessary. Develops and maintains key quality and compliance performance metrics. Participates in developing and presenting departmental materials for Management Reviews. Promotes a culture of Regulatory Compliance and Risk Management throughout the organization. Coaches and guides Quality System Auditors and supports staff as required to ensure appropriate control systems are in place and continually optimized to meet changing regulatory, corporate and industry standards. Maintains current knowledge of regulatory changes through industry publications, seminars, professional affiliation and industry meetings. Supports departmental and franchise objectives while adhering to the values of the Johnson & Johnson Credo and local safety and environmental policy and procedure.
Qualifications
A Bachelor's degree and a minimum of four (4) years of professional work experience within a quality or compliance audit environment is required. A degree in Engineering, a Life Science or a related technical discipline is preferred. A Master's degree is highly desirable, preferably an MBA. Experience working in a Medical Device / Pharmaceutical / Biologics manufacturing environment is required. Certification as a Lead Auditor is required. ASQ CQA, CQE, CBA or Qualified ISO Lead Assessor certification is preferred. A minimum of 2 years of experience conducting and/or leading regulatory assessments in a global context, in a regulated environment is preferred. Prior experience supporting External Regulatory and/or Notified Body Inspections (e.g. FDA, BSi etc) is preferred. Strong communication, organization, negotiation and interpersonal skills are required. Strong statistical and analytical problem solving skills are required. The ability to collaborate with all levels of management across multiple sites and functions is required.
This position will be located in Cornelia, GA 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-Georgia-Cornelia
Organization:
Ethicon Inc. (6045)
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 SupplementEstimated Salary: $20 to $28 per hour based on qualifications.
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