Senior Manager, CSV Equipment Validation-00000V6Z
Description
DePuy Synthes Companies of Johnson & Johnson is the largest, most comprehensive orthopedic and neurological business in the world. DePuy Synthes offer an unparalleled breadth and depth of technology, devices, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, cranio-maxillofacial, 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. Our broad array of inspired, innovative and high-quality offerings help advance the health and wellbeing of people around the world.
For our Computer System Validation Team we are looking for a highly committed Senior Manager, CSV Equipment Validation
As a key member of the Computer System Validation team you will be leading multiple CSV Equipment Teams worldwide, providing technical and procedural expertise, guidance and analysis across the DePuy Synthes Organization. We expect you to:
- Develop, maintain and support Quality Systems, Equipment and Tools for Computer System Validation (CSV) / Part 11
- Deploy as a single CSV Equipment Quality Management System (QMS) across the Franchise
- Monitor and analyze internal performance and nonconforming events to ensure the appropriate corrective actions are taken for all worldwide facilities
- Understand, incorporate and comply with all applicable laws and regulations relating to DePuy Synthes business activities and Policies and Procedures of the Health Care Compliance Program and Code of Conduct.
- Ensure compliance with the Worldwide Policies on Information Asset Protection, maintain passwords as Confidential, and protect Critical Business Information
- Perform internal and/or supplier audits (Supplier Management) of Software Suppliers, Software Consultants, etc.
- Serve in a project leadership role for establishing and improving CSV/CSV Equipment/Part 11 processes worldwide
- Evaluate and implement processes and program improvements utilizing Process/Design Excellence Tools
- Evaluate and implement new technology to improve software quality, reduce cost, achieve business results and/or enhance employee safety
- Suggest and implement tactical direction for worldwide solutions.
- Research and benchmark creative solutions
- Develop, implement and conduct training in Software Quality Systems and procedures to enhance efficiency and compliance across the Franchise
- Train Business and IT associates on the proper use of systems and tools and track compliance against their use
- Participate, as appropriate, in J&J compliance activities to leverage processes to improve business results
Qualifications
- A minimum of a Bachelor’s Degree in in Engineering / Computer Science / Information Systems OR 4 years of equivalent experience is required
- ASQ certification as a Software Quality Engineer is desirable
- Minimum 3 years of experience as Quality Engineer and/or Software Quality Engineer working with equipment and business computers
- Additional experience in functional areas outside of Quality (e.g. IT, OPS, MFG) would be a bonus
- Cross-company/facility experience desirable
- Proven success record in managing an international team
- Demonstrated performance with leading cross-departmental projects
- Experience in managing cross-facility projects is highly desirable
- Understanding use of approved corporate Quality Systems software applications (i.e. Agile, SAP, etc) and shop floor equipment (CNC, CMM, etc)
- Demonstrated ability to prioritize and manage multiple projects while meeting deadlines/budgets
- Demonstrated ability to develop and implement project plans that result in positive business results
- Excellent interpersonal communication and problem solving skills, ability to build strong relationships with internal and external customers
Are you a passionate problem solver, willing to have an impact on complex issues? Do you feel attracted by leading a truly global team spread across multiple locations? Then please send us your online application (CV, Motivation Letter, Working References etc.).
Primary Location:Europe/Middle East/Africa
Other Locations:North America
Organization: Synthes GmbH (7111)
Job Function: Quality
Description
DePuy Synthes Companies of Johnson & Johnson is the largest, most comprehensive orthopedic and neurological business in the world. DePuy Synthes offer an unparalleled breadth and depth of technology, devices, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, cranio-maxillofacial, 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. Our broad array of inspired, innovative and high-quality offerings help advance the health and wellbeing of people around the world.
For our Computer System Validation Team we are looking for a highly committed Senior Manager, CSV Equipment Validation
As a key member of the Computer System Validation team you will be leading multiple CSV Equipment Teams worldwide, providing technical and procedural expertise, guidance and analysis across the DePuy Synthes Organization. We expect you to:
- Develop, maintain and support Quality Systems, Equipment and Tools for Computer System Validation (CSV) / Part 11
- Deploy as a single CSV Equipment Quality Management System (QMS) across the Franchise
- Monitor and analyze internal performance and nonconforming events to ensure the appropriate corrective actions are taken for all worldwide facilities
- Understand, incorporate and comply with all applicable laws and regulations relating to DePuy Synthes business activities and Policies and Procedures of the Health Care Compliance Program and Code of Conduct.
- Ensure compliance with the Worldwide Policies on Information Asset Protection, maintain passwords as Confidential, and protect Critical Business Information
- Perform internal and/or supplier audits (Supplier Management) of Software Suppliers, Software Consultants, etc.
- Serve in a project leadership role for establishing and improving CSV/CSV Equipment/Part 11 processes worldwide
- Evaluate and implement processes and program improvements utilizing Process/Design Excellence Tools
- Evaluate and implement new technology to improve software quality, reduce cost, achieve business results and/or enhance employee safety
- Suggest and implement tactical direction for worldwide solutions.
- Research and benchmark creative solutions
- Develop, implement and conduct training in Software Quality Systems and procedures to enhance efficiency and compliance across the Franchise
- Train Business and IT associates on the proper use of systems and tools and track compliance against their use
- Participate, as appropriate, in J&J compliance activities to leverage processes to improve business results
Qualifications
- A minimum of a Bachelor’s Degree in in Engineering / Computer Science / Information Systems OR 4 years of equivalent experience is required
- ASQ certification as a Software Quality Engineer is desirable
- Minimum 3 years of experience as Quality Engineer and/or Software Quality Engineer working with equipment and business computers
- Additional experience in functional areas outside of Quality (e.g. IT, OPS, MFG) would be a bonus
- Cross-company/facility experience desirable
- Proven success record in managing an international team
- Demonstrated performance with leading cross-departmental projects
- Experience in managing cross-facility projects is highly desirable
- Understanding use of approved corporate Quality Systems software applications (i.e. Agile, SAP, etc) and shop floor equipment (CNC, CMM, etc)
- Demonstrated ability to prioritize and manage multiple projects while meeting deadlines/budgets
- Demonstrated ability to develop and implement project plans that result in positive business results
- Excellent interpersonal communication and problem solving skills, ability to build strong relationships with internal and external customers
Are you a passionate problem solver, willing to have an impact on complex issues? Do you feel attracted by leading a truly global team spread across multiple locations? Then please send us your online application (CV, Motivation Letter, Working References etc.).
Primary Location:Europe/Middle East/Africa
Other Locations:North America
Organization: Synthes GmbH (7111)
Job Function: Quality