Senior Manager-Post Market Quality - Colorado Springs, CO

Job summary

The Senior Manager-Post Market Quality plays an important role within Philips Image Guided Therapy Devices (IGTD) quality organization by ensuring compliance of complaint handling returned device analysis processes and assessment of quality issues for Recall/Correction & Removal decisions.

Responsibilities

• Establishes Post Market Quality operational objectives/work plans, delegates assignments to subordinates to ensure smooth execution/efficient distribution of tasks within the organization and fosters collaboration/productivity while aligning with overarching goals.
• Manages talent across the quality assurance team, while driving employee selection, performance management, compensation management, career development, and ensuring effective operational management.
• Reviews and monitors operational key performance indicators (KPIs) to evaluate the success of operations, actively participates in the development, modification, and execution of company policies impacting immediate operations, with potential implications across the organization.
• Implements quality assurance policies and strategies to determine methods, techniques, and evaluation criteria in quality assurance, ensuring alignment with organizational objectives for optimal outcomes.
• Directs product recall procedures, ensures swift and efficient resolution in accordance with company policies and regulatory standards, and oversees all aspects of the device issue evaluations for decision and recall process (if applicable) to maintain compliance and uphold consumer safety.
• Supports in external and internal audits, aids in regulatory compliance gap closure, monitors complaint handling and Correction & Removal quality metrics, agreements, and records.
• Formulates/implements the Business' long-range quality, regulatory and compliance policy and creates Q&R awareness level as determined within the organization.
• Enforces (a simplified) quality system and harmonizes them across the Business sites and Sector; establish an effective Management Review process, including routine reporting with action for negative trends.
• Manages: compliance with FDA regulations/Regulatory Agencies guidelines and policies, the review and approval of finished products in accordance with approved specifications (includes Complaint handling) and product recall activities to include recall policies and procedures for the company.

Job description