J&J Family of Companies Process & Technology Transformation - Senior Quality Leader in Cork, Ireland
DePuy Synthes Companies of Johnson & Johnson is seeking a Pro-Active Quality Technology Leader within the Quality Engineering Continuous Improvement Group. The person will be located in either Cork, Ireland, US West Chester, US Raynham or Zuchwill, Switzerland.
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.
Leads the Technology Quality function within Quality Operations for DePuySynthes
This position leads the Quality function for the development and Implemention of innovative technology transformation.
Advance Quality principles in order to drive continuous improvement and improve product and process quality.
The incumbent must be able to function as both an individual contributor and an overall leader of activities in a matrixed organization.
He/She will develop quality strategies in support of the respective DePuySynthes plants and the business objectives.
This person is responsible for planning and coordinating future technology driven Quality Operations Organizational capabilities development
Working in partnership with the Quality Ops and Engineering Leadership Team, the incumbent is responsible for ensuring that products are manufactured in accordance with J&J requirements and FDA regulations, as well as all applicable international regulatory requirements.
The incumbent will work closely with key business stakeholders (i.e. plant, business unit, and sector staff, across multiple functions including Operations, Engineering and Quality) to drive strategic development, execution and flawless communication
This individual is responsible for innovative technology transformation portfolio management for Quality Operations, including resourcing, budgetary and capex requirements
Comply with J&J Safety Requirement and safe working conditions and practices in the department.
POSITION DUTIES & RESPONSIBILITIES:
Assists in developing strategy as well as Goals and Objectives for Quality Operations.
Enables effective deployment across the Quality Operations Organization of procedures and methodologies to ensure high product quality as well as compliance with J&J requirements, FDA and global quality system requirements.
Ability to handle a variety of individual projects while directing the efforts of resources at the same time.
Represent Quality as a core/or ad-hoc team member for Engineering Virtual Teams.
Lead effectively in a high complex matrixed environment working at Enterprise, Sector and company level. This role requires close collaboration with Engineering, Product Management, Quality Ops, Lean & Operations.
This role requires active benchmarking to identify best practices, capture Stakeholder VOC and effectively convert those Quality User Requirements in the development of technology innovative applications.
Effectively communicate at different levels within the organization (strategic business acumen & quality technology SME). Areas of focus include but are not limited to: CCPs, Testing & Inspection, Digital Systems, Packaging etc.
Collaborate with Virtual Teams in the development of strategic Technology Roadmaps
Drive Total Cost of Quality, better compliance environment, product quality and recall prevention
EDUCATION & EXPERIENCE REQUIREMENTS:
A minimum of a University/Bachelor's degree in an Engineering, Scientific, or related field required.
M.S., M.B.A., or advanced degree highly preferred.
A minimum of a Bachelors Degree, preferably in Engineering or related technical field. Generally requires 8-10 years related experience including 4-6 years specific experience in a management/supervisory role.
Experience in the medical device field required.
ASQ Engineer certification a plus.
Process Excellence training or certification preferred (Lean, Six Sigma, DeX,FPX)
Working knowledge of US and International regulations governing the medical device industry (i.e., GMP, GLPs, MDR, and ISO 13485: 2003) required.
Strong managerial skills and ability to manage multiple departmental budgets required.
Excellent communication skills (verbal and written) and problem solving skills required.
Knowledge of fundamental quality engineering principles such as Process Validation, Design of Experiments, and Process Control & Capability required.
Knowledgeable in matrix management and able to work collaboratively cross-functionally as well as across business units required.
A person of strong conviction with effective persuasion skills must be comfortable making objective decisions and taking decisive action.
Capable of assuming technical hands-on leadership required.
Team player, able to bring diverse people and opinions together to provide the optimum solutions for the company, its employees and customers required.
In instances, this position may require travel to multiple locations (30-50%) and will be based in a DePuySynthes facility
Depuy (Ireland) Limited (7386)