Johnson & Johnson companies are equal opportunity employers.
Associate Director, Quality Systems & Compliance - MD&D Medical Safety-5194131211
Description
Medical Devices & Diagnostics Global Services, LLC, a division of the Johnson & Johnson Family of Companies, is recruiting for an Associate Director, Quality Systems and Compliance, MD&D Medical Safety. The preferred location for this position is Bridgewater, New Jersey, however this position can be based at any MD&D location in the US.
Medical Devices & Diagnostics Global Services, LLC., 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 organization 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 Associate Director, Quality Systems and Compliance, MD&D Medical Safety supports establishment and maintenance of Johnson & Johnson MD&D Office of the Chief Medical Officer overall quality management framework and quality system. Supports establishing appropriate systems for oversight of medical safety across the sector with a focus on Medical Safety Council processes and accountabilities, ensuring compliance to attain world-class operational capabilities, product safety and regulatory compliance. This position reports to the Director, Quality Systems and Compliance, MD&D Medical Safety.
The Associate Director, Quality Systems and Compliance, MD&D Medical Safety works with the Director, Quality Systems and Compliance, MD&D Medical Safety, as well as members of the Office of the CMO MD&D and Medical Safety Stakeholders, ensuring a proactive approach to quality assurance and quality systems. Drives and coordinates the implementation of Quality systems and tools required by the MD&D Office of the CMO, so the Office can meet the responsibilities delineated in Enterprise Safety Standard and the MD&D Medical Safety Council Charter. Coordinates quality investigations and/or internal audits to assess conformance to Sector policies and overall compliance to regulations. Supports development of appropriate strategic and process performance measures/targets. Works closely with the MD&D Quality Systems and Quality & Compliance groups to leverage knowledge to transfer J&J proven quality tools and programs. Operates as a key business partner for quality and process improvement, understand business requirements and execute quality programs to drive organizational capability building related to medical safety across MD&D.
This individual establishes and maintains global and local collaborations with partnering organizations. Leads cross-functional teams and provide subject matter expertise to other functions. Participates on Global Quality System initiatives related to MD&D Medical Safety Quality system needs as appropriate. Entrenches a process improvement culture within the business. Implements process management practices, verify/validate project results. Engages relevant personnel in these initiatives, through interactive project coaching/consulting and change management strategies. Partners with Professional Development Lead in the Office of the CMO to ensure appropriate personnel are trained in process improvement methodologies, techniques, tools, language etc. Strengthens the overall quality capability in the region and develop a rich and diverse pipeline of talent within the Quality community.
Qualifications
A Bachelor’s degree and a minimum of 5 years of relevant experience is required. An MBA or equivalent is an asset. A degree in Business, Biosciences, Engineering or an equivalent field is desired. Experience working in a medium to large scale cross-functional, matrixed environment is required. The ability to influence without authority is required. Process Excellence experience is required. Black belt or related experience in Six Sigma, Design Excellence, Lean Thinking and Performance Dashboards is preferred. A proven track record of participating in cross-functional teams to achieve significant quality and process improvements is required.
Proven experience with ISO13485 or equivalent quality standards is required. The ability to proactively identify improvement opportunities is required. Excellent influencing and interpersonal skills, as well as the ability to influence and interact at multiple levels of the organization, manage multiple priorities, and deliver excellent results is required. Strong influencing and collaboration skills, and excellent written and verbal communications skills are required. Relevant experience in the healthcare or pharmaceutical industry is preferred. Change management experience is an asset. PE Business Assessment experience is an asset.
Up to approximately 10% domestic travel may be required. The preferred location for this position is Bridgewater, New Jersey, however this position can be based at any MD&D location in the US.
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
Primary Location:North America-United States-New Jersey-New Brunswick
Other Locations:North America-United States
Organization: Johnson & Johnson (6067)
Job Function: Quality Systems
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
Associate Director, Quality Systems & Compliance - MD&D Medical Safety-5194131211
Description
Medical Devices & Diagnostics Global Services, LLC, a division of the Johnson & Johnson Family of Companies, is recruiting for an Associate Director, Quality Systems and Compliance, MD&D Medical Safety. The preferred location for this position is Bridgewater, New Jersey, however this position can be based at any MD&D location in the US.
Medical Devices & Diagnostics Global Services, LLC., 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 organization 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 Associate Director, Quality Systems and Compliance, MD&D Medical Safety supports establishment and maintenance of Johnson & Johnson MD&D Office of the Chief Medical Officer overall quality management framework and quality system. Supports establishing appropriate systems for oversight of medical safety across the sector with a focus on Medical Safety Council processes and accountabilities, ensuring compliance to attain world-class operational capabilities, product safety and regulatory compliance. This position reports to the Director, Quality Systems and Compliance, MD&D Medical Safety.
The Associate Director, Quality Systems and Compliance, MD&D Medical Safety works with the Director, Quality Systems and Compliance, MD&D Medical Safety, as well as members of the Office of the CMO MD&D and Medical Safety Stakeholders, ensuring a proactive approach to quality assurance and quality systems. Drives and coordinates the implementation of Quality systems and tools required by the MD&D Office of the CMO, so the Office can meet the responsibilities delineated in Enterprise Safety Standard and the MD&D Medical Safety Council Charter. Coordinates quality investigations and/or internal audits to assess conformance to Sector policies and overall compliance to regulations. Supports development of appropriate strategic and process performance measures/targets. Works closely with the MD&D Quality Systems and Quality & Compliance groups to leverage knowledge to transfer J&J proven quality tools and programs. Operates as a key business partner for quality and process improvement, understand business requirements and execute quality programs to drive organizational capability building related to medical safety across MD&D.
This individual establishes and maintains global and local collaborations with partnering organizations. Leads cross-functional teams and provide subject matter expertise to other functions. Participates on Global Quality System initiatives related to MD&D Medical Safety Quality system needs as appropriate. Entrenches a process improvement culture within the business. Implements process management practices, verify/validate project results. Engages relevant personnel in these initiatives, through interactive project coaching/consulting and change management strategies. Partners with Professional Development Lead in the Office of the CMO to ensure appropriate personnel are trained in process improvement methodologies, techniques, tools, language etc. Strengthens the overall quality capability in the region and develop a rich and diverse pipeline of talent within the Quality community.
Qualifications
A Bachelor’s degree and a minimum of 5 years of relevant experience is required. An MBA or equivalent is an asset. A degree in Business, Biosciences, Engineering or an equivalent field is desired. Experience working in a medium to large scale cross-functional, matrixed environment is required. The ability to influence without authority is required. Process Excellence experience is required. Black belt or related experience in Six Sigma, Design Excellence, Lean Thinking and Performance Dashboards is preferred. A proven track record of participating in cross-functional teams to achieve significant quality and process improvements is required.
Proven experience with ISO13485 or equivalent quality standards is required. The ability to proactively identify improvement opportunities is required. Excellent influencing and interpersonal skills, as well as the ability to influence and interact at multiple levels of the organization, manage multiple priorities, and deliver excellent results is required. Strong influencing and collaboration skills, and excellent written and verbal communications skills are required. Relevant experience in the healthcare or pharmaceutical industry is preferred. Change management experience is an asset. PE Business Assessment experience is an asset.
Up to approximately 10% domestic travel may be required. The preferred location for this position is Bridgewater, New Jersey, however this position can be based at any MD&D location in the US.
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
Primary Location:North America-United States-New Jersey-New Brunswick
Other Locations:North America-United States
Organization: Johnson & Johnson (6067)
Job Function: Quality Systems
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