Prin Quality Systems Spec

About the role

Support key Quality System processes, including Quality System Change Orders, training, CAPAs, issue escalation, internal and external audits, and data analysis.

Responsibilities

• Support the end-to-end CAPA process, including initiation, root cause analysis, action planning, implementation tracking, verification, and closure, to ensure timely and effective resolution of quality issues in compliance with internal procedures and regulatory requirements.
• Review and approve training plans associated with change orders to ensure training requirements are appropriately defined, documented, and completed.
• Support continuous improvement activities by helping to implement improvements to strengthen quality system effectiveness and efficiency.
• Support key organizational initiatives and cross-functional priorities as needed.

Requirements

• Strong understanding of global regulatory requirements for medical devices, including FDA Quality Management System Regulation (QMSR), ISO 13485, and European Medical Device Regulation.
• Strong understanding of quality systems, including CAPA, change control, training, and management review.
• Familiarity with risk management and root cause analysis tools.
• Bachelor's degree required.
• 7 years of relevant experience required (or 5 years with an advanced degree).

Skills & competencies

• Mastery of a specialty area and full knowledge of industry practices.
• Broad knowledge of project management.
• Ability to manage large projects or processes with considerable autonomy and limited oversight.
• Capability to coach, review, and delegate work to lower-level specialists.
• Strong communication and influence skills, representing the organization as a primary contact for projects and initiatives.
• Ability to negotiate with internal and external customers and vendors.
• Leadership and talent management capabilities, including providing guidance, coaching, and training to others.

Pay

$66–81 per hour, depending on experience.