Sr. Development Quality Engineer - Katalyst Healthcares & Life Sciences

• 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.

Requirements:

• 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.