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Supervisor, Recall Execution (Quality Assurance)-7954131017
Description
DePuy Synthes Companies of Johnson & Johnson is seeking a Supervisor, Recall Execution 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.
The Supervisor, Recall Execution’s primary responsibilities include oversight of activities associated with DePuy Synthes recall and field action execution and reporting activities as well as direct management of Recall Execution Specialists.
The Supervisor, Recall Execution will ensure documentation (procedures, forms, etc) is in place to clearly define required reporting activities and records for handling DePuy Synthes recalls. He/she will continually assess internal department procedures and ensure they remain in compliance with applicable regulations and standards (i.e. 21CFR 806 & part 7, CMDR, MEDDEV 2.12-1, etc). This individual will serve as the functional area leader for recall reporting and will manage the process from wing to wing, including all correspondences with regulatory agencies within required time frames as applicable. The Supervisor, Recall Execution will host and attend group meetings to review open tasks and ensure resources are delegated appropriately. He/she will notify management of any potential resource constraints. This individual will identify potentials for improvement and streamlining to current process as well as notify management of potential and lead effort for implementation. The Supervisor, Recall Execution will serve as subject matter expert for recall reporting on a daily basis. He/she will provide feedback and guidance to Recall Execution Specialists for continuous improvement. This individual will support global recall and field action projects as the subject matter expert. The Supervisor, Recall Execution will support internal and external audits as subject matter expert for recalls as determined necessary by management. As necessary, he/she will perform the responsibilities of a Recall Execution Specialist to assist in the timely initiation and communication of recalls. This individual will ensure recall information is tracked / trended and communicated in order to provide manufacturing plants and Product Development with the necessary information to assess their own areas of responsibility relative to product quality. The Supervisor, Recall Execution will 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. He/she will diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer. This individual will promote and nurture the highest standards of professionalism, ethics and compliance, and actively support our compliance program-related initiatives and activities. He/she will consistently enforce employee compliance, including attendance at training programs, and promptly report any non-compliance to the Chief Compliance Officer.
Qualifications
A minimum of a Bachelor’s Degree is required. A minimum of 6 years of experience in a GMP and/or ISO regulated environment is required. Experience in a clinical environment practicing human medicine is preferred. A minimum of 4 years of direct people management experience is required. A history of strong people skills for the proper development and management of department employees is required. Knowledge and understanding of regulatory requirements relative to complaint handling is preferred. Knowledge of internal and external bone fixation devices and implants is preferred. Recall investigation is preferred. Previous experience with the execution and/or reporting of recalls or field safety notices is required. Experience or general medical knowledge of Orthopedic, Spine, and Craniofacial/ Maxillofacial implants and instruments is preferred. Working knowledge of 21CFR 806 & part 7, CMDR and MEDDEV 2.12-1 is required. General knowledge of the requirements for medical devices and MDR, MPR, and Vigilance reporting is preferred. Orthopedic Surgery knowledge is preferred. Strong communication (written, oral and listening) skills are required. Experience and/or comfortability interacting with the FDA is strongly preferred. Excellent organizational and time management skills are required. Critical thinking skills are required. RAC or ASQ certifications are preferred. This position will be based in West Chester, PA and will require up to 20% travel, including potential international.
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: Compliance
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.
Supervisor, Recall Execution (Quality Assurance)-7954131017
Description
DePuy Synthes Companies of Johnson & Johnson is seeking a Supervisor, Recall Execution 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.
The Supervisor, Recall Execution’s primary responsibilities include oversight of activities associated with DePuy Synthes recall and field action execution and reporting activities as well as direct management of Recall Execution Specialists.
The Supervisor, Recall Execution will ensure documentation (procedures, forms, etc) is in place to clearly define required reporting activities and records for handling DePuy Synthes recalls. He/she will continually assess internal department procedures and ensure they remain in compliance with applicable regulations and standards (i.e. 21CFR 806 & part 7, CMDR, MEDDEV 2.12-1, etc). This individual will serve as the functional area leader for recall reporting and will manage the process from wing to wing, including all correspondences with regulatory agencies within required time frames as applicable. The Supervisor, Recall Execution will host and attend group meetings to review open tasks and ensure resources are delegated appropriately. He/she will notify management of any potential resource constraints. This individual will identify potentials for improvement and streamlining to current process as well as notify management of potential and lead effort for implementation. The Supervisor, Recall Execution will serve as subject matter expert for recall reporting on a daily basis. He/she will provide feedback and guidance to Recall Execution Specialists for continuous improvement. This individual will support global recall and field action projects as the subject matter expert. The Supervisor, Recall Execution will support internal and external audits as subject matter expert for recalls as determined necessary by management. As necessary, he/she will perform the responsibilities of a Recall Execution Specialist to assist in the timely initiation and communication of recalls. This individual will ensure recall information is tracked / trended and communicated in order to provide manufacturing plants and Product Development with the necessary information to assess their own areas of responsibility relative to product quality. The Supervisor, Recall Execution will 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. He/she will diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer. This individual will promote and nurture the highest standards of professionalism, ethics and compliance, and actively support our compliance program-related initiatives and activities. He/she will consistently enforce employee compliance, including attendance at training programs, and promptly report any non-compliance to the Chief Compliance Officer.
Qualifications
A minimum of a Bachelor’s Degree is required. A minimum of 6 years of experience in a GMP and/or ISO regulated environment is required. Experience in a clinical environment practicing human medicine is preferred. A minimum of 4 years of direct people management experience is required. A history of strong people skills for the proper development and management of department employees is required. Knowledge and understanding of regulatory requirements relative to complaint handling is preferred. Knowledge of internal and external bone fixation devices and implants is preferred. Recall investigation is preferred. Previous experience with the execution and/or reporting of recalls or field safety notices is required. Experience or general medical knowledge of Orthopedic, Spine, and Craniofacial/ Maxillofacial implants and instruments is preferred. Working knowledge of 21CFR 806 & part 7, CMDR and MEDDEV 2.12-1 is required. General knowledge of the requirements for medical devices and MDR, MPR, and Vigilance reporting is preferred. Orthopedic Surgery knowledge is preferred. Strong communication (written, oral and listening) skills are required. Experience and/or comfortability interacting with the FDA is strongly preferred. Excellent organizational and time management skills are required. Critical thinking skills are required. RAC or ASQ certifications are preferred. This position will be based in West Chester, PA and will require up to 20% travel, including potential international.
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: Compliance
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.