Katalyst Healthcares and Life Sciences
Responsibilities:
- Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member).
- Lead on-time completion of Quality deliverables and business initiatives.
- Support the definition of objective, measurable, discrete, and verifiable customer requirements and product requirements.
- Lead Risk Management activities including analyzing field data to support Failure Mode Effects Analysis and Hazard Analysis.
- Support Test and Inspection Method development including Method Validation activities.
- Support Design Verification and Design Validation planning and execution, including cross.
- functional root-cause analysis investigation and resolution activities.
- Support manufacturing process development and qualification for design changes on Commercial products.
- Support Supplier related changes for Commercial products.
- Maintain high standards for Device History File (DHF) content completion, integrity, and regulatory.
- standards compliance; collaboratively identifying, communicating, and resolving gaps.
- Support, review, and approve Document Change Order in a timely manner.
- Lead, coach, and mentor junior engineers.
- Be innovative, resourceful, and work with minimal direction. Have excellent organization, problem solving, communication, and team leadership skills. Work effectively with cross-functional teams.
- Build strong collaborative partnerships with cross functional teams including Program Management.
- Research & Development, Regulatory Affairs, Supplier Quality, Manufacturing Quality, Manufacturing.
- Engineering and Process Development to ensure cross functional customer needs are met without creating barriers to development cost, time, and scope.
- Support regulatory audits as a Subject Matter Expert for Design Controls and other aspects of the quality system.
- Support and ensure internal & external audit responses and on-time product re-certifications.
- Writes and revises SOPs, controlled forms, and related documents to ensure best practices and maintain compliance.
- Own Corrective Action/Preventive Action (CAPA) investigations.
- Additional duties may be identified by functional management based on current project/business objectives.
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements.
- Company policies, operating procedures, processes, and task assignments.
- Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.