Johnson & Johnson companies are equal opportunity employers.
DIRECTOR, WORLDWIDE CUSTOMER QUALITY-7910130920
Description
Advanced Sterilization Products Division of Ethicon, Inc., a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Director Worldwide Customer Quality, located in
Irvine, CA.
ASP (Advanced Sterilization Products), a member of the Johnson & Johnson Family of Companies, is a leading designer and developer of innovative instrument sterilization, high-level disinfection and cleaning technologies. The company is dedicated to providing infection prevention solutions that create the safest possible environments for patients, healthcare providers, and communities. ASP is based in Irvine, California with offices around the world. For more information, please visit www.aspjj.com or follow us at www.Twitter.com/aspjj.
The Director, Worldwide Customer Quality is responsible for the establishing the vision and leading the ASP Worldwide Complaint Management team in achieving and delivering world-class systems and support, driving continuous improvement in reporting, data management of customer complaints, and driving talent development. Position is also responsible for driving timely and effective improvements in product and process performance and for reporting to Sr. Management on the suitability and effectiveness of the ASP complaint management and regulatory reporting systems.
Lead the WW Customer Quality team in implementing ASP strategies and objectives. Monitor worldwide regulatory and technical standards environments for shift in complaint management trends. Assess impact on ASP and implement changes to policies and procedures as required.
Develop & implement appropriate metrics to track & monitor complaint management lifecycle to include but not limited to Regulatory Reporting, cycle time, and backlog
Create quality goals and objectives in alignment with department, company and corporate objectives, and the J&J Credo
Provide leadership to organization to ensure that all processes and systems comply with established specifications & regulations
Provide leadership to all R&D, Supply Chain, Service and commercial organizations with respect to global complaint management
Interact with the global health authorities and J&J Legal Services as required. Lead health authority inspections as required for complaint management and medical reporting
Provide Leadership for Complaint Investigations
Establish and ensure the strategic direction & continuous improvement of ASP reporting & data management of customer complaints. Assure, maintain & develop adequate complaint handling and reporting processes and systems to support the business
Ensure AP upper management is informed of the status of complaint handling programs including significant customer events & complaint trends
Partner with Marketing, Sales, Quality & other departments to ensure the delivery of world-class complaint management
Participate in cost reductions & lean improvement programs
Complete & deliver performance reviews of direct reports, and establish associate performance and potential ratings
Contract with direct reports to develop viable development plans & objectives; facilitate, coach & manage associates through the development process
Manage Complaint Management system technology and process improvement Projects
Other responsibilities may be assigned & not all responsibilities listed may be assigned.
Qualifications
BS, Degree in Engineering, Science, Business or Business Management or Quality Systems Management is required, advanced degree in Engineering, Science, Management or Quality Systems Management is preferred.
A minimum of 10 or more years of complaint handling leadership experience in Quality Assurance and/or Quality Systems within a Medical Device, Diagnostic, Pharmaceutical or other regulated industry is required, capital equipment experience is preferred.
CQE (Quality Engineer certification), CRE (Reliability Engineer certification), CQA (Quality Auditor certification), CQM (Quality Manager certification, Certified ISO Auditor, and/or PE certification are preferred
Excellent communication skills both written and oral are required.
Experience in Quality Systems Development is required. Experience in MDR and adverse reporting on a global basis is required.
Process Excellence Black Belt is preferred. Field sales or service experience is preferred.
This position will be based in Irvine, CA and will require up to 10 % domestic and/ or international 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.
J2W:LI
Primary Location:North America-United States-California-Irvine
Organization: Advanced Sterilization Products (ASP)
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.
DIRECTOR, WORLDWIDE CUSTOMER QUALITY-7910130920
Description
Advanced Sterilization Products Division of Ethicon, Inc., a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Director Worldwide Customer Quality, located in
Irvine, CA.
ASP (Advanced Sterilization Products), a member of the Johnson & Johnson Family of Companies, is a leading designer and developer of innovative instrument sterilization, high-level disinfection and cleaning technologies. The company is dedicated to providing infection prevention solutions that create the safest possible environments for patients, healthcare providers, and communities. ASP is based in Irvine, California with offices around the world. For more information, please visit www.aspjj.com or follow us at www.Twitter.com/aspjj.
The Director, Worldwide Customer Quality is responsible for the establishing the vision and leading the ASP Worldwide Complaint Management team in achieving and delivering world-class systems and support, driving continuous improvement in reporting, data management of customer complaints, and driving talent development. Position is also responsible for driving timely and effective improvements in product and process performance and for reporting to Sr. Management on the suitability and effectiveness of the ASP complaint management and regulatory reporting systems.
Lead the WW Customer Quality team in implementing ASP strategies and objectives. Monitor worldwide regulatory and technical standards environments for shift in complaint management trends. Assess impact on ASP and implement changes to policies and procedures as required.
Develop & implement appropriate metrics to track & monitor complaint management lifecycle to include but not limited to Regulatory Reporting, cycle time, and backlog
Create quality goals and objectives in alignment with department, company and corporate objectives, and the J&J Credo
Provide leadership to organization to ensure that all processes and systems comply with established specifications & regulations
Provide leadership to all R&D, Supply Chain, Service and commercial organizations with respect to global complaint management
Interact with the global health authorities and J&J Legal Services as required. Lead health authority inspections as required for complaint management and medical reporting
Provide Leadership for Complaint Investigations
Establish and ensure the strategic direction & continuous improvement of ASP reporting & data management of customer complaints. Assure, maintain & develop adequate complaint handling and reporting processes and systems to support the business
Ensure AP upper management is informed of the status of complaint handling programs including significant customer events & complaint trends
Partner with Marketing, Sales, Quality & other departments to ensure the delivery of world-class complaint management
Participate in cost reductions & lean improvement programs
Complete & deliver performance reviews of direct reports, and establish associate performance and potential ratings
Contract with direct reports to develop viable development plans & objectives; facilitate, coach & manage associates through the development process
Manage Complaint Management system technology and process improvement Projects
Other responsibilities may be assigned & not all responsibilities listed may be assigned.
Qualifications
BS, Degree in Engineering, Science, Business or Business Management or Quality Systems Management is required, advanced degree in Engineering, Science, Management or Quality Systems Management is preferred.
A minimum of 10 or more years of complaint handling leadership experience in Quality Assurance and/or Quality Systems within a Medical Device, Diagnostic, Pharmaceutical or other regulated industry is required, capital equipment experience is preferred.
CQE (Quality Engineer certification), CRE (Reliability Engineer certification), CQA (Quality Auditor certification), CQM (Quality Manager certification, Certified ISO Auditor, and/or PE certification are preferred
Excellent communication skills both written and oral are required.
Experience in Quality Systems Development is required. Experience in MDR and adverse reporting on a global basis is required.
Process Excellence Black Belt is preferred. Field sales or service experience is preferred.
This position will be based in Irvine, CA and will require up to 10 % domestic and/ or international 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.
J2W:LI
Primary Location:North America-United States-California-Irvine
Organization: Advanced Sterilization Products (ASP)
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.