Johnson & Johnson companies are equal opportunity employers.
Quality Engineer II-5067131205
Description
DePuy Synthes Companies of Johnson & Johnson is currently recruiting for a Quality Engineer II position for Product Complaint Management in Raynham, Mass.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic 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.
DePuy Synthes Mitek is the Sports Medicine business offers orthopaedic sports medicine products, soft tissue repair devices, joint movement solutions and minimally invasive and arthroscopic solutions.
The Quality Engineer II will perform activities such investigation of customer complaints for product quality issues and concerns. He/she will initiate product failure investigations and take the lead in failure investigation teams. The Quality Engineer II will conduct health hazard evaluations working with manufacturing, R&D, and Medical Affairs personnel as required.
In this role the Quality Engineer II position will develop and utilize statistical tools to analyze complaints for trends, root cause analysis, and initiation of corrective action. This role will be summarizing the results of various data analysis into clear and concise presentations and reports for peers, cross-functional teams and management. This will include summarizing data to support activities such as post market surveillance, routine complaint reports, regulatory agency responses etc.
This Quality Engineer II role will also interface with key business partners including R&D, Operations, Medical, Marketing and Post Market Safety Surveillance to ensure thorough investigations are completed. Investigations can include user interviews and occasional customer visits to ensure rapid response to field safety issues. Depending upon the nature of the identified safety issue/product quality event, the Quality Engineer II will be the key interface with the Product Escalation group to ensure all events are escalated in a timely manner and per procedure. Providing daily support to the complaint team and help drive complaint investigations with various manufacturing sites in the U.S. and internationally ensuring complaint investigations are robust and well documented.
Qualifications
A minimum of Bachelors Degree in Engineering is required. A Biomedical Engineering, Mechanical Engineering or Electrical Engineering degree is highly preferred. A minimum of 3 years experience in the medical device or related field (ie: Biologics) is required. Excellent problem solving, decision-making, and root cause analysis skills is required. Strong proficiency with the Microsoft Office Suite is required. Strong working knowledge of the QSR and ISO quality requirements is preferred. Knowledge of process and design excellence tools and Six Sigma training are a plus. Strong data analysis and technical writing skills required. Excellent communication and presentation skills are required. The ideal candidate for this role will have the ability to collaborate with business partners at all levels across multiple functional groups in an environment that embraces teamwork and risk-based decision making.
This position may require up to 10% travel and is based in Raynham, MA and does not offer relocation benefits.
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-Massachusetts-Raynham
Organization: Depuy Orthopaedics. Inc. (6029)
Job Function: Quality (Eng)
Travel:No
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
Quality Engineer II-5067131205
Description
DePuy Synthes Companies of Johnson & Johnson is currently recruiting for a Quality Engineer II position for Product Complaint Management in Raynham, Mass.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic 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.
DePuy Synthes Mitek is the Sports Medicine business offers orthopaedic sports medicine products, soft tissue repair devices, joint movement solutions and minimally invasive and arthroscopic solutions.
The Quality Engineer II will perform activities such investigation of customer complaints for product quality issues and concerns. He/she will initiate product failure investigations and take the lead in failure investigation teams. The Quality Engineer II will conduct health hazard evaluations working with manufacturing, R&D, and Medical Affairs personnel as required.
In this role the Quality Engineer II position will develop and utilize statistical tools to analyze complaints for trends, root cause analysis, and initiation of corrective action. This role will be summarizing the results of various data analysis into clear and concise presentations and reports for peers, cross-functional teams and management. This will include summarizing data to support activities such as post market surveillance, routine complaint reports, regulatory agency responses etc.
This Quality Engineer II role will also interface with key business partners including R&D, Operations, Medical, Marketing and Post Market Safety Surveillance to ensure thorough investigations are completed. Investigations can include user interviews and occasional customer visits to ensure rapid response to field safety issues. Depending upon the nature of the identified safety issue/product quality event, the Quality Engineer II will be the key interface with the Product Escalation group to ensure all events are escalated in a timely manner and per procedure. Providing daily support to the complaint team and help drive complaint investigations with various manufacturing sites in the U.S. and internationally ensuring complaint investigations are robust and well documented.
Qualifications
A minimum of Bachelors Degree in Engineering is required. A Biomedical Engineering, Mechanical Engineering or Electrical Engineering degree is highly preferred. A minimum of 3 years experience in the medical device or related field (ie: Biologics) is required. Excellent problem solving, decision-making, and root cause analysis skills is required. Strong proficiency with the Microsoft Office Suite is required. Strong working knowledge of the QSR and ISO quality requirements is preferred. Knowledge of process and design excellence tools and Six Sigma training are a plus. Strong data analysis and technical writing skills required. Excellent communication and presentation skills are required. The ideal candidate for this role will have the ability to collaborate with business partners at all levels across multiple functional groups in an environment that embraces teamwork and risk-based decision making.
This position may require up to 10% travel and is based in Raynham, MA and does not offer relocation benefits.
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-Massachusetts-Raynham
Organization: Depuy Orthopaedics. Inc. (6029)
Job Function: Quality (Eng)
Travel:No
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