Johnson & Johnson Careers
Staff Quality Systems Engineer
West Chester, Pennsylvania
Requisition ID: 8875190329
Depuy Synthes is recruiting a Staff Quality Systems Engineer to join the quality systems department. The Staff Quality Systems Engineer supports the development and implementation of quality systems designed to ensure continuous production of product consistent with established standards and customer expectations.
DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit http://www.depuysynthes.com.
In this role, you will independently evaluate software in the business relative to GMP (Good Manufacturing Practices), ISO (International Organization for Standardization) and MDD (Medical Devices Directive). You will also evaluate, develop, redesign and implement programs associated with improvements to business solutions. This role also requires account management/ project management including: day to day task and project planning, following quality processes and procedures; interacting with and supporting customers; and developing and implementing process to support software quality. This also includes knowledge of the Software Development Lifecycle (SDLC).
As a Staff Quality Systems Engineer, you will:
- Know and follow policies and procedures related to work activities performed in area of responsibility.
- Complete training in area of responsibility within allowed time-period. Training is required for changes in existing policies and procedures, for new assignments and for implementation of new policies and procedures. Complete required periodic re-training in areas such as safety and environmental.
- Follow all company safety policies and other safety precautions within work area. Promote safety to all associates that enter work area.
- Plan, develop and implement process to support Software Configuration Management.
- Plan, develop and implement training regarding software regulatory requirements, software validation, and software configuration management.
- Review software projects to ensure defined processes are followed. This process should be in conformance with all defined process and procedures.
- Provide a focal point for GMP/ISO/GCP/21CFR Part 11 expertise in the Quality Systems group for consultation.
- Interact successfully with individuals and groups on behalf of the Quality Systems department.
- Provide guidance to the organization during software development to ensure all processes and procedures relating to the software in development are clearly documented.
- Provide consultation to project teams on validation documentation for business enabling software.
- Lead projects that deal with implementation of business solutions, software validation, corrective actions for software projects, software quality and regulatory software compliance.
- Liaison with other Medical Device companies for best in class and benchmarking opportunities.
- Participate in crafting strategies for building company wide systems that support quality.
- Other responsibilities may be assigned and not all responsibilities listed in the Senior level may be assigned.
- A minimum of a Bachelor's Degree in a scientific, business, or administrative area is required.
- A minimum of 3 years of experience in medical device, pharmaceuticals, biologics or similar regulated industry is required.
- Experience with and knowledge of:
- GMP regulations, GCP regulations, ISO standards and their application in a design and manufacturing environment is required.
- Integrated process and structure within existing business systems is preferred.
- Configuration management, change management and project management is required.
- Documentation processes and systems is required.
- FDA (Food and Drug Administration) and ISO requirements as related to documentation is required.
- The ability to collaborate with affiliate sites (domestic and international), secondary users, as well as, sales and marketing is required.
- Being customer centric is required.
- The ability to work collaboratively and cross-functionally is required.
- Team building: The ability to lead, guide and facilitate is required.
- The ability to be discerning and solve problems by being able to distinguish regulatory from desirable user requirement when developing and improving systems is required.
- Project scheduling, planning, tracking and reporting is required.
- Time Management is required.
- This role may require up to 10% of travel both domestically and internationally.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United States-Pennsylvania-West Chester-
Depuy Orthopaedics. Inc. (6029)