Director, Process Compliance & Centers of Excellence

Director, Process Compliance & Centers of Excellence

The Director, Process Compliance & Centers of Excellence is responsible for spearheading the strategic development and deployment of robust Enterprise quality controls and process improvements. They will lead organization-wide compliance initiatives, proactively drive integration of new tools & processes, and analyze data for trends and risks. Your role:
Drives strategic initiatives to elevate supplier quality standards, collaborating closely with cross-functional teams in Research & Development (R&D), manufacturing, and regulatory affairs to address process gaps and maintain superior quality benchmarks. Guides setup of acceptance activities, including transfer to manufacturing resolve process deficiencies and develop New Product Introduction (NPI) validations, process development, process controls, inspection plans, and control plans. Collaborates with Quality Optimization team to integrate initiatives into site QMS processes.

Analyzes data to identify trends, risks, and improvement opportunities and proactively support process improvement. Drive cost reduction and productivity through analysis of Cost of Poor Quality (COPQ) data and assist teams with implementation of cost saving initiatives Manages compliance with industry regulations and oversees the preparation and maintenance of documentation. Leads talent management, and succession planning and develops a high-performing team aligned with organizational goals.

Authorizes the assessment of impact to Process Failure Mode and Effects Analysis (PFMEA) and associated controls in relation to design changes and assists in Manufacturing Process Development and Design Transfer activities. Mentors and cultivate a culture of continuous learning and knowledge sharing among quality engineers, ensuring effective support for New Product Introduction (NPI) projects and seamless product transfers within the manufacturing facility.

Possesses expert knowledge of products/services and advanced quality engineering techniques, recognized as expert within the field, and frequently interacts with senior management on matters around several functional areas. Works on complex issues, drawing on an in-depth understanding of the organization to analyze situations effectively, actively contributing to the development of organizational objectives and principles. Possesses broad cross-functional experience, demonstrates leadership exposure in a technical capacity, and is familiar with project management practices.

Leads succession planning and comprehensive talent management, driving employee selection, performance management, compensation management, and career development in alignment with organizational operational goals.

• You have a minimum of 10+ years’ experience in FDA regulated medical device environments, with extensive focus in QMS Compliance, CAPA process, Internal Audit, and process/continuous improvement.
• You have a minimum of 5+ years’ experience in functional/strategic leadership of quality teams/organizations within global, matrixed organizations.
• You have robust understanding and deep knowledge of FDA 21 CFR Part 820, ISO 13485, EUMDR and other global medical device standards.
• You have detailed knowledge in Risk Management (ISO 14971), PFMEA, root cause analysis and design transfer activities.
• You have extensive experience leading/supporting regulatory inspections (FDA, Notified Bodies)
• You have proven experience leading strategic process validation initiatives, CAPA processes, Non-Conformances (NC) and Quality Notifications (QN).
• You have a minimum of a Bachelor’s degree (Required) in Engineering, Life Sciences, or related technical field - Master’s degree preferred (MBA, MS, or…