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
- Ability to Understand and Translate Customer Needs (Explicit And Implied); Customer Facing Metric Development
- A minimum of a Bachelors’ Degree, preferably in Engineering or related technical field.
- M.S., M.B.A., or advanced degree highly preferred.
- Requires 8+ years related experience including 4+years specific experience in a management/supervisory role.
- Experience in the medical device, pharmaceutical or other highly regulated field is 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) is highly preferred.
- 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%)
Requisition ID: 0225180119