Johnson & Johnson companies are equal opportunity employers.
Quality Engineer II-5354140922
Description
DePuy Synthes Joint Reconstruction, a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Engineer II, located in Warsaw, IN.
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.
DePuy Synthes Joint Reconstruction is the Orthopaedic division offering a comprehensive portfolio of Orthopaedic Implant solutions for the treatment of the simplest to the most complex joint disorders using traditional and minimally invasive techniques.
The Quality Engineer II should excel in an environment that embraces teamwork, change, risk-based decision-making and flexibility. This individual will work in a design team setting. This role predominantly performs Post-Market Surveillance activities including trend analyses, signal assessments and investigations. The individual will execute the Post-Market Surveillance process with a primary focus on signal assessment and detailed investigations and reports of potential Safety Issues and Quality Trend Events. This position will consult with and support the business as it develops and implements product-specific safety surveillance strategies in proactive and systematic detection and evaluation of potential safety signals and emerging trends from post-marketing safety surveillance data.
The Quality Engineer II will perform all job duties in full accordance with the Worldwide Policies on Information Asset Protection, maintain password(s) as Confidential, and protect Critical Business Information. This individual will have intimate knowledge of research and product development, trade secrets, government reporting and legal matters, and strategic quality initiatives. This individual will be able to communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Regulatory, Manufacturing, and Marketing. Some of the main duties and responsibilities are as follows:
Support the product post market surveillance process from a technical Quality perspective by leading Signal Assessment Investigations, evaluating Safety Signals and evaluating potential Safety Issues/Product Quality Events against all know PMS Data sets with the intent of confirming the issues/event.
Interface with the PMS data analytics team to review signal analysis and detection data focusing on trends, triggers and control limits in PMS data that represent a potential Safety Issue/Product Quality Event. Identify and evaluate potential emerging safety signals and trends by conducting systematic reviews of aggregate data with a focus on spontaneous adverse event reports.
Prepare Safety Signal Reports for Leadership as well as prepare Post Market Surveillance data and analysis for reviews with Business Unit Leadership teams.
Depending upon the nature of the identified safety issue/product quality event, the Quality Engineer will be the key interface with the Product Escalation group to ensure all events are escalated in a timely manner and per procedure
Qualifications
A minimum of a Bachelor's degree in an Engineering, Technical, or Scientific discipline is required. A minimum of 2 years experience is required. Preferably within a regulated environment (e.g. FDA regulated) An Advanced degree in a related field is an asset. The ability to work independently and partner with a cross-functional team is required. Quality Engineering/Design or Process Excellence/Lean experience is an asset. ASQ certifications are an asset. Experience conducting Process / Design Failure Mode Effects and Analysis is an asset. Mechanical product knowledge is preferred. Problem solving techniques including root cause analysis and cause and effect analysis are all preferred. Statistical techniques and methods are preferred. Knowledge of the QSR, Design Controls, and ISO quality requirements is preferred. Excellent negotiation, decision-making, and interpersonal skills that foster conflict resolution as it relates to technical situations is desired.
Prior project management experience is preferred. Working knowledge of Microsoft office products (Word, Excel, Access, and Project) is required. Excellent written and oral communication skills are required. The ability to use Quality Engineering principles, tools, and practices to develop and optimize systems and processes that are aligned with the overall business and quality vision is required.
This position will be based in Warsaw, IN, and will require up to 10% 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.
Primary Location:North America-United States-Indiana-Warsaw
Organization: Depuy Products Inc. (6030)
Job Function: Quality (Eng)
Relocation: Eligible No
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
Quality Engineer II-5354140922
Description
DePuy Synthes Joint Reconstruction, a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Engineer II, located in Warsaw, IN.
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.
DePuy Synthes Joint Reconstruction is the Orthopaedic division offering a comprehensive portfolio of Orthopaedic Implant solutions for the treatment of the simplest to the most complex joint disorders using traditional and minimally invasive techniques.
The Quality Engineer II should excel in an environment that embraces teamwork, change, risk-based decision-making and flexibility. This individual will work in a design team setting. This role predominantly performs Post-Market Surveillance activities including trend analyses, signal assessments and investigations. The individual will execute the Post-Market Surveillance process with a primary focus on signal assessment and detailed investigations and reports of potential Safety Issues and Quality Trend Events. This position will consult with and support the business as it develops and implements product-specific safety surveillance strategies in proactive and systematic detection and evaluation of potential safety signals and emerging trends from post-marketing safety surveillance data.
The Quality Engineer II will perform all job duties in full accordance with the Worldwide Policies on Information Asset Protection, maintain password(s) as Confidential, and protect Critical Business Information. This individual will have intimate knowledge of research and product development, trade secrets, government reporting and legal matters, and strategic quality initiatives. This individual will be able to communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Regulatory, Manufacturing, and Marketing. Some of the main duties and responsibilities are as follows:
Support the product post market surveillance process from a technical Quality perspective by leading Signal Assessment Investigations, evaluating Safety Signals and evaluating potential Safety Issues/Product Quality Events against all know PMS Data sets with the intent of confirming the issues/event.
Interface with the PMS data analytics team to review signal analysis and detection data focusing on trends, triggers and control limits in PMS data that represent a potential Safety Issue/Product Quality Event. Identify and evaluate potential emerging safety signals and trends by conducting systematic reviews of aggregate data with a focus on spontaneous adverse event reports.
Prepare Safety Signal Reports for Leadership as well as prepare Post Market Surveillance data and analysis for reviews with Business Unit Leadership teams.
Depending upon the nature of the identified safety issue/product quality event, the Quality Engineer will be the key interface with the Product Escalation group to ensure all events are escalated in a timely manner and per procedure
Qualifications
A minimum of a Bachelor's degree in an Engineering, Technical, or Scientific discipline is required. A minimum of 2 years experience is required. Preferably within a regulated environment (e.g. FDA regulated) An Advanced degree in a related field is an asset. The ability to work independently and partner with a cross-functional team is required. Quality Engineering/Design or Process Excellence/Lean experience is an asset. ASQ certifications are an asset. Experience conducting Process / Design Failure Mode Effects and Analysis is an asset. Mechanical product knowledge is preferred. Problem solving techniques including root cause analysis and cause and effect analysis are all preferred. Statistical techniques and methods are preferred. Knowledge of the QSR, Design Controls, and ISO quality requirements is preferred. Excellent negotiation, decision-making, and interpersonal skills that foster conflict resolution as it relates to technical situations is desired.
Prior project management experience is preferred. Working knowledge of Microsoft office products (Word, Excel, Access, and Project) is required. Excellent written and oral communication skills are required. The ability to use Quality Engineering principles, tools, and practices to develop and optimize systems and processes that are aligned with the overall business and quality vision is required.
This position will be based in Warsaw, IN, and will require up to 10% 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.
Primary Location:North America-United States-Indiana-Warsaw
Organization: Depuy Products Inc. (6030)
Job Function: Quality (Eng)
Relocation: Eligible No
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