Johnson & Johnson companies are equal opportunity employers.
Recall Investigation Engineer-8835140114
Description
DePuy Synthes Companies of Johnson & Johnson is seeking a Recall Investigation Engineer 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.
Complaint Handling Unit (CHU) member responsible for supporting activities associated with field actions. The Recall Specialist will be responsible for the oversight and direct support of technical evaluations and investigational tasks required for recall investigations. The Recall Specialist will communicate with Quality Engineers, Manufacturing, Product Development and other functional experts as needed to ensure clear understanding/investigation of applicable issues.
POSITION DUTIES & RESPONSIBILITIES:
Direct interface with Hospitals, Surgeons, and Internal Synthes employees for investigations; Preparing for and attending all recall investigation meetings on behalf of the Complaint Handling Unit; Reporting 806 documents to the FDA; Provide guidance and direction to peers, serve as expert in field action and complaint handling process; Preparing updates to FDA for Open Field Actions; Responding to external questions regarding field actions. Serve as internal expert regarding open field actions; Preparing Weekly and Quarterly Complaint Handling Reports; Responsible for processing and closing complaints in a timely manner; Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times; Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer. Additional duties as assigned.
Qualifications
A minimum of a Bachelor’s Degree is required. A Bachelor’s Degree in engineering or life science is preferred. A minimum of 5 years of direct experience in a medical device quality or regulatory role is required. A minimum 5 of years of experience in a regulated industry (medical device or pharmaceutical) is required. Recall investigation experience is strongly preferred. Previous root-cause analysis skills are preferred and experience conducting and reviewing product complaint investigations are also preferred. Post market regulatory, quality or compliance experience is also preferred. A proven track record in design verification/validation, process verification/validation, and design/process failure modes and effects analyses is strongly preferred. Must be highly organized and have the ability to prioritize job functions with attention to detail and within required timeframes. Must also be able to work in an open office environment and work independently and prioritize with little supervision. Strong written and oral communication and interpersonal (listening) skills are required. Must have ability to lead efforts aimed at the identification of problematic situations, the reporting of issues, and the development of resolutions and decision making. RAC or ASQ certifications are a plus. Familiarity with basic quality tools and techniques, EtQ or similar system is preferred. Analytical and critical thinking skills are required. This role will be based in West Chester, PA.
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-Pennsylvania-West Chester
Organization: Depuy Orthopaedics. Inc. (6029)
Job Function: Quality Assurance
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
Recall Investigation Engineer-8835140114
Description
DePuy Synthes Companies of Johnson & Johnson is seeking a Recall Investigation Engineer 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.
Complaint Handling Unit (CHU) member responsible for supporting activities associated with field actions. The Recall Specialist will be responsible for the oversight and direct support of technical evaluations and investigational tasks required for recall investigations. The Recall Specialist will communicate with Quality Engineers, Manufacturing, Product Development and other functional experts as needed to ensure clear understanding/investigation of applicable issues.
POSITION DUTIES & RESPONSIBILITIES:
Direct interface with Hospitals, Surgeons, and Internal Synthes employees for investigations; Preparing for and attending all recall investigation meetings on behalf of the Complaint Handling Unit; Reporting 806 documents to the FDA; Provide guidance and direction to peers, serve as expert in field action and complaint handling process; Preparing updates to FDA for Open Field Actions; Responding to external questions regarding field actions. Serve as internal expert regarding open field actions; Preparing Weekly and Quarterly Complaint Handling Reports; Responsible for processing and closing complaints in a timely manner; Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times; Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer. Additional duties as assigned.
Qualifications
A minimum of a Bachelor’s Degree is required. A Bachelor’s Degree in engineering or life science is preferred. A minimum of 5 years of direct experience in a medical device quality or regulatory role is required. A minimum 5 of years of experience in a regulated industry (medical device or pharmaceutical) is required. Recall investigation experience is strongly preferred. Previous root-cause analysis skills are preferred and experience conducting and reviewing product complaint investigations are also preferred. Post market regulatory, quality or compliance experience is also preferred. A proven track record in design verification/validation, process verification/validation, and design/process failure modes and effects analyses is strongly preferred. Must be highly organized and have the ability to prioritize job functions with attention to detail and within required timeframes. Must also be able to work in an open office environment and work independently and prioritize with little supervision. Strong written and oral communication and interpersonal (listening) skills are required. Must have ability to lead efforts aimed at the identification of problematic situations, the reporting of issues, and the development of resolutions and decision making. RAC or ASQ certifications are a plus. Familiarity with basic quality tools and techniques, EtQ or similar system is preferred. Analytical and critical thinking skills are required. This role will be based in West Chester, PA.
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-Pennsylvania-West Chester
Organization: Depuy Orthopaedics. Inc. (6029)
Job Function: Quality Assurance
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