Johnson & Johnson companies are equal opportunity employers.
Director, QA Complaint Handling and Safety Surveillance-5944130417
Description
DePuy Synthes Companies of Johnson & Johnson is seeking a Director, QA Complaint Handling and Safety Surveillance in West Chester, PA.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies will 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, we are creating one organization that will be agile and better equipped in 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 Director, QA Complaint Handling and Safety Surveillance will hire and organize department of medical and technical professionals such that we are able to meet all safety, regulatory and quality requirements in an efficient, process-oriented manner. This individual will develop talent for future positions at DePuy Synthes and/or J&J. He/she will implement automated systems that can obtain data in a consistent manner, allow appropriate and trending for signal detection, and provide reports to management on a monthly basis regarding trends. This individual will ensure metrics cover all patient issues for concomitant medical treatment as well as technical overview of complaints. He/she will ensure systems are current, validated and implemented on a worldwide basis. The Director, QA Complaint Handling and Safety Surveillance will manage a team to include: technical complaint group, medical safety surveillance group, clinical reports/complaints. He/she will develop and report critical monthly metrics. This individual will work closely with Medical/Clinical Group to ensure consistency in medical evaluations, Quality Board decisions and overall Safety evaluations of product. He/she will provide feedback to Development organization on potential areas for improvement for DePuy Synthes product. The Director, QA Complaint Handling and Safety Surveillance will develop and implement program to review literature for technical and medical review of DePuy Synthes and competitive product. He/she will develop and implement risk assessment for safety and technical evaluations.
Qualifications
A minimum of a Bachelors Degree is required. Candidates must have a minimum of 15 years experience in a regulated industry or possess a Masters Degree with a minimum of 10 years experience in a regulated industry. A minimum of 5 years of complaint handling experience in medical devices is required. Previous people management experience is required. Knowledge of the medical device marketplace usually associated with some successful experience in one or more of the following is required: marketing, sales, customer service or technical applications. Experience in orthopaedics is preferred. Understanding of health hazard evaluations is required. Experience interacting with the FDA required. Excellent communications and analytical skills are required. Working knowledge of Microsoft Office, Excel, Power Point, and Access is required.
This position will be based in West Chester, PA and will require up to 25% 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
Primary Location:North America-United States-Pennsylvania-West Chester
Organization: Depuy Orthopaedics. Inc. (6029)
Job: Quality Assurance
Travel:Yes, 25% 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.
Director, QA Complaint Handling and Safety Surveillance-5944130417
Description
DePuy Synthes Companies of Johnson & Johnson is seeking a Director, QA Complaint Handling and Safety Surveillance in West Chester, PA.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies will 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, we are creating one organization that will be agile and better equipped in 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 Director, QA Complaint Handling and Safety Surveillance will hire and organize department of medical and technical professionals such that we are able to meet all safety, regulatory and quality requirements in an efficient, process-oriented manner. This individual will develop talent for future positions at DePuy Synthes and/or J&J. He/she will implement automated systems that can obtain data in a consistent manner, allow appropriate and trending for signal detection, and provide reports to management on a monthly basis regarding trends. This individual will ensure metrics cover all patient issues for concomitant medical treatment as well as technical overview of complaints. He/she will ensure systems are current, validated and implemented on a worldwide basis. The Director, QA Complaint Handling and Safety Surveillance will manage a team to include: technical complaint group, medical safety surveillance group, clinical reports/complaints. He/she will develop and report critical monthly metrics. This individual will work closely with Medical/Clinical Group to ensure consistency in medical evaluations, Quality Board decisions and overall Safety evaluations of product. He/she will provide feedback to Development organization on potential areas for improvement for DePuy Synthes product. The Director, QA Complaint Handling and Safety Surveillance will develop and implement program to review literature for technical and medical review of DePuy Synthes and competitive product. He/she will develop and implement risk assessment for safety and technical evaluations.
Qualifications
A minimum of a Bachelors Degree is required. Candidates must have a minimum of 15 years experience in a regulated industry or possess a Masters Degree with a minimum of 10 years experience in a regulated industry. A minimum of 5 years of complaint handling experience in medical devices is required. Previous people management experience is required. Knowledge of the medical device marketplace usually associated with some successful experience in one or more of the following is required: marketing, sales, customer service or technical applications. Experience in orthopaedics is preferred. Understanding of health hazard evaluations is required. Experience interacting with the FDA required. Excellent communications and analytical skills are required. Working knowledge of Microsoft Office, Excel, Power Point, and Access is required.
This position will be based in West Chester, PA and will require up to 25% 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
Primary Location:North America-United States-Pennsylvania-West Chester
Organization: Depuy Orthopaedics. Inc. (6029)
Job: Quality Assurance
Travel:Yes, 25% 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.