Johnson & Johnson companies are equal opportunity employers.
Senior Quality Engineer, Risk Management-9139131008
Description
DePuy Synthes Companies of Johnson & Johnson is seeking a Senior Quality Engineer, Risk Management to be located in West Chester, PA.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopedic and neurological business in the world. DePuy Synthes Companies offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, more agile and better equipped to meet the needs of today’s evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.
This role will report to the Director of Risk Management for DePuy Synthes and supports the development of Risk Management in line with FDA QSR, ISO 13485 and ISO1497.
The candidate will ensure effective Risk Management processes are in place to support safe and effective medical devices are developed, produced and maintained. He or she will identify opportunities to continuously improve Risk Management as a system thereby improving patient safety.
He or she will also provide backroom support for 3rd Party Inspections and Audits (e.g. Registrar, Notified Body, FDA, or customer audits), provides training regarding Risk Management and Quality Management System Elements to representatives from other functional areas. The Senior Quality Engineer will identify opportunities to continuously improve quality systems and processes in alignment with overall quality and business objectives, support and participate in cross-functional projects when assigned/appropriate, facilitate technical innovations to enhance Quality Systems and support business goals, as well as assist with other Quality System activities as requested by management.
Maintain overall management and effectiveness of Risk Management including the process and application. Implement and maintain measures to monitor the effectiveness of the Risk Management process. Ensure processes are in place to alert management of product quality & compliance issues for proper and timely escalation to Management Review. Ensure Risk Management processes are in compliance with applicable regulations and standards of monitoring process are routinely communicated to management through the Management Review process.
Some responsibilities include:
Monitor risk management system on site.
Train relevant staff in Risk Management.
Subject Matter Expert in Risk Management (RM) including RM process ownership.
Maintain and report System and Site Risk Metrics to Senior Management.
Support the organization in RM methodology by identifying risks, applying applicable risk tools, quantifying risks and report/share risks in the organization.
Propose risk reduction programs and improvements to system and sites.
Qualifications
A minimum of a Bachelor's Degree is required. An MS Degree in Engineering, Science, Business or related discipline is preferred. The ideal candidate will possess extensive experience in Risk Management, design quality engineering, experienced in identifying risks, and/or implementing risk management tools/training on risk management in a regulated environment. Must have the ability to lead a high performance team and drive performance results; excellent working knowledge of FDA QSR (Quality Systems Regulations) device design controls; excellent communication skills both written and verbal; and the ability to work and communicate in a cross-cultural environment. A minimum of 5+ years of experience in medical device manufacturing, cGMP, and/or other equally regulated environment is required. Proven record of delivering robust risk management solutions to support the overall business (in alignment with ISO 14971, QSR’s and/or ISO 13485) is required. Must be a problem solver with strong influencing, lobbying and analytical skills. The ideal candidate must have good technical skills related to risk management system and tools, as well as demonstrated knowledge of business impact of compliance issues. Experience in the concepts of Lean Six Sigma/ Continuous Improvement, Project Management and/or Process management is required. A good working knowledge of related functions (cross functional partnerships) such as Product Development, Operations, Supplier Management and/or Procurement is required. Experience in auditing to FDA QSR, ISO 9001/ISO 13485/ISO 14971 standards, additionally a working knowledge of PAL and other related medical device national regulatory standards is an asset. ASQ certifications (CQE, CRE or CQA or other relevant certifications) are desired. This position will be based in West Chester, PA and require up to 15% travel, including possible 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-Pennsylvania-West Chester
Organization: Depuy Orthopaedics. Inc. (6029)
Job: Quality (Eng)
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.
Senior Quality Engineer, Risk Management-9139131008
Description
DePuy Synthes Companies of Johnson & Johnson is seeking a Senior Quality Engineer, Risk Management to be located in West Chester, PA.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopedic and neurological business in the world. DePuy Synthes Companies offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, more agile and better equipped to meet the needs of today’s evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.
This role will report to the Director of Risk Management for DePuy Synthes and supports the development of Risk Management in line with FDA QSR, ISO 13485 and ISO1497.
The candidate will ensure effective Risk Management processes are in place to support safe and effective medical devices are developed, produced and maintained. He or she will identify opportunities to continuously improve Risk Management as a system thereby improving patient safety.
He or she will also provide backroom support for 3rd Party Inspections and Audits (e.g. Registrar, Notified Body, FDA, or customer audits), provides training regarding Risk Management and Quality Management System Elements to representatives from other functional areas. The Senior Quality Engineer will identify opportunities to continuously improve quality systems and processes in alignment with overall quality and business objectives, support and participate in cross-functional projects when assigned/appropriate, facilitate technical innovations to enhance Quality Systems and support business goals, as well as assist with other Quality System activities as requested by management.
Maintain overall management and effectiveness of Risk Management including the process and application. Implement and maintain measures to monitor the effectiveness of the Risk Management process. Ensure processes are in place to alert management of product quality & compliance issues for proper and timely escalation to Management Review. Ensure Risk Management processes are in compliance with applicable regulations and standards of monitoring process are routinely communicated to management through the Management Review process.
Some responsibilities include:
Monitor risk management system on site.
Train relevant staff in Risk Management.
Subject Matter Expert in Risk Management (RM) including RM process ownership.
Maintain and report System and Site Risk Metrics to Senior Management.
Support the organization in RM methodology by identifying risks, applying applicable risk tools, quantifying risks and report/share risks in the organization.
Propose risk reduction programs and improvements to system and sites.
Qualifications
A minimum of a Bachelor's Degree is required. An MS Degree in Engineering, Science, Business or related discipline is preferred. The ideal candidate will possess extensive experience in Risk Management, design quality engineering, experienced in identifying risks, and/or implementing risk management tools/training on risk management in a regulated environment. Must have the ability to lead a high performance team and drive performance results; excellent working knowledge of FDA QSR (Quality Systems Regulations) device design controls; excellent communication skills both written and verbal; and the ability to work and communicate in a cross-cultural environment. A minimum of 5+ years of experience in medical device manufacturing, cGMP, and/or other equally regulated environment is required. Proven record of delivering robust risk management solutions to support the overall business (in alignment with ISO 14971, QSR’s and/or ISO 13485) is required. Must be a problem solver with strong influencing, lobbying and analytical skills. The ideal candidate must have good technical skills related to risk management system and tools, as well as demonstrated knowledge of business impact of compliance issues. Experience in the concepts of Lean Six Sigma/ Continuous Improvement, Project Management and/or Process management is required. A good working knowledge of related functions (cross functional partnerships) such as Product Development, Operations, Supplier Management and/or Procurement is required. Experience in auditing to FDA QSR, ISO 9001/ISO 13485/ISO 14971 standards, additionally a working knowledge of PAL and other related medical device national regulatory standards is an asset. ASQ certifications (CQE, CRE or CQA or other relevant certifications) are desired. This position will be based in West Chester, PA and require up to 15% travel, including possible 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-Pennsylvania-West Chester
Organization: Depuy Orthopaedics. Inc. (6029)
Job: Quality (Eng)
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.