Johnson & Johnson companies are equal opportunity employers.
Complaint Investigation Engineer II-1026140519
Description
DePuy Synthes Spine, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Complaint Investigation Engineer II located in Raynham, MA.
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 Spine is the Spine business offering a comprehensive portfolio of spinal care solutions for the treatment of the most simple to the most complex spine disorders using traditional and minimally invasive techniques.
The Complaint Investigation Engineer II will perform activities such as triage of incoming complaints and documenting requirements for evaluations and investigations. He/she will evaluate and investigate customer complaints for product quality issues and concerns and will initiate and lead projects involving failure investigations, root cause analysis, utilize statistical tools to analyze complaints and corrective actions. This individual will take the lead in failure investigations, participate in health hazard evaluations, work with manufacturing, R&D, and Medical Affairs personnel including working with international affiliates as required. The Complaint Investigation Engineer II will be summarizing the results of various data analysis into clear and concise presentations and reports for peers, cross-functional teams and management. He/she will be summarizing data to support activities such as post market surveillance, routine complaint reports, regulatory agency responses etc.
This Complaint Investigation Engineer II role will also interface with key business partners including R&D, Operations, Post Market Risk Management and Surveillance and Quality, Regulatory and Compliance Management to ensure a thorough investigation is completed. Investigations can include user interviews and manufacturing and product development visits to ensure rapid response to field safety issues. Depending upon the nature of the identified safety issue/product quality event, the Complaint Investigation Engineer II will be the key interface to ensure all events are escalated in a timely manner and per procedure. He/she will be gathering data working with and preparing responses for the U.S. and International Regulatory agencies, which often make inquiries into individual or groups of product complaints. This individual will be 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. The Complaint Investigation Engineer II will assist in training and mentoring of new employees, provide guidance and direction to peers, and serve as an expert in complaint investigation process.
Qualifications
A minimum of Bachelor’s Degree in Engineering is required. A minimum of 2 years of experience in a GMP and/or ISO regulated environment is required. Medical device industry experience is preferred. Previous root cause analysis skills are required. Experience conducting and reviewing product complaint investigations are highly preferred. Prior project management/leadership experience is preferred. 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 is required. Knowledge of process and design excellence tools and/or Green, or Black Belt training is preferred. Proficiency with the Microsoft Office Suite is required. Knowledge and experience with CAD software (Pro-E, AutoCAD, Medusa, etc.) are highly preferred. Excellent communication and presentation skills are required. Excellent organizational, problem solving and decision-making skills are required.
This role will be based in Raynham, MA and travel up to 10%, including light 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 NA
Primary Location:North America-United States-Massachusetts-Raynham
Organization: Depuy Orthopaedics. Inc. (6029)
Job Function: 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.
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
Complaint Investigation Engineer II-1026140519
Description
DePuy Synthes Spine, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Complaint Investigation Engineer II located in Raynham, MA.
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 Spine is the Spine business offering a comprehensive portfolio of spinal care solutions for the treatment of the most simple to the most complex spine disorders using traditional and minimally invasive techniques.
The Complaint Investigation Engineer II will perform activities such as triage of incoming complaints and documenting requirements for evaluations and investigations. He/she will evaluate and investigate customer complaints for product quality issues and concerns and will initiate and lead projects involving failure investigations, root cause analysis, utilize statistical tools to analyze complaints and corrective actions. This individual will take the lead in failure investigations, participate in health hazard evaluations, work with manufacturing, R&D, and Medical Affairs personnel including working with international affiliates as required. The Complaint Investigation Engineer II will be summarizing the results of various data analysis into clear and concise presentations and reports for peers, cross-functional teams and management. He/she will be summarizing data to support activities such as post market surveillance, routine complaint reports, regulatory agency responses etc.
This Complaint Investigation Engineer II role will also interface with key business partners including R&D, Operations, Post Market Risk Management and Surveillance and Quality, Regulatory and Compliance Management to ensure a thorough investigation is completed. Investigations can include user interviews and manufacturing and product development visits to ensure rapid response to field safety issues. Depending upon the nature of the identified safety issue/product quality event, the Complaint Investigation Engineer II will be the key interface to ensure all events are escalated in a timely manner and per procedure. He/she will be gathering data working with and preparing responses for the U.S. and International Regulatory agencies, which often make inquiries into individual or groups of product complaints. This individual will be 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. The Complaint Investigation Engineer II will assist in training and mentoring of new employees, provide guidance and direction to peers, and serve as an expert in complaint investigation process.
Qualifications
A minimum of Bachelor’s Degree in Engineering is required. A minimum of 2 years of experience in a GMP and/or ISO regulated environment is required. Medical device industry experience is preferred. Previous root cause analysis skills are required. Experience conducting and reviewing product complaint investigations are highly preferred. Prior project management/leadership experience is preferred. 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 is required. Knowledge of process and design excellence tools and/or Green, or Black Belt training is preferred. Proficiency with the Microsoft Office Suite is required. Knowledge and experience with CAD software (Pro-E, AutoCAD, Medusa, etc.) are highly preferred. Excellent communication and presentation skills are required. Excellent organizational, problem solving and decision-making skills are required.
This role will be based in Raynham, MA and travel up to 10%, including light 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 NA
Primary Location:North America-United States-Massachusetts-Raynham
Organization: Depuy Orthopaedics. Inc. (6029)
Job Function: 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.
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