Senior Manager-Post Market Quality

Philips•San Diego, CA

3d•Onsite

About The Position

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. This role 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. It involves introducing and implementing the quality processes and tools required to ensure product quality and customer satisfaction. The Senior Manager also manages talent across the quality assurance team, driving employee selection, performance management, compensation management, career development, and ensuring effective operational management. The role 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. It implements quality assurance policies and strategies to determine methods, techniques, and evaluation criteria in quality assurance, ensuring alignment with organizational objectives for optimal outcomes. The position 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. It supports in external and internal audits, aids in regulatory compliance gap closure, monitors complaint handling and Correction & Removal quality metrics, agreements, and records. The Senior Manager formulates/implements the Business’ long-range quality, regulatory and compliance policy and creates Q&R awareness level as determined within the organization. The role enforces a simplified quality system and harmonizes them across the Business sites and Sector; establishes an effective Management Review process, including routine reporting with action for negative trends. It 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.

Requirements

Minimum of 10+ years’ experience in Post Market Quality within FDA regulated medical device/product environments, with proven experience in Quality Planning, Complaint Handling, returns, investigations, Corrections & Removals, Recalls, QMS simplification/harmonization, CAPA’s, Internal/External Audit-compliance to FDA regulations/Regulatory Agencies guidelines and policies.
Minimum of 3+ years’ experience managing Post Market Quality teams, including employee selection, performance management, compensation management, career development, effective operational management and fostering a culture of continuous improvement/quality excellence in customer relations within the team.
Detailed knowledge of medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971, European Medical Device Directive (93/42/EEC), EU Medical Device Regulation, Canadian Medical Devices Regulation (SOR/98-282), and Japanese MHLW Ordinance 169.
Minimum of a Bachelor’s Degree (required) in Engineering, Quality or related disciplines.
Ability to successfully perform the minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

Nice To Haves

Master’s degree desired

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.
Introduce and implement the quality processes and tools required to ensure product quality and customer satisfaction.
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.