QMS Specialist

Philips•Latham, NY

3d•Hybrid

About The Position

In this role you The QMS Specialist is a member of the Operations Quality team in Latham which ensures compliance with legal, regulatory, and international standards as they apply to Latham’s Quality Management System. This individual is responsible for documentation, process improvement, and execution of QMS procedures and work instructions to ensure change is executed in a controlled manner and in compliance with applicable regulations.

Requirements

4+ years of experience in Quality Management Systems, Quality Audits or equivalent in highly regulated environments/industries such as MD, Pharma, Automotive with Vocational Education.
3+ years of experience with QMS in medical device
General understanding of ISO9001:2015 / ISO13485:2016 / Good Manufacturing Practices (GMP).
Regulatory, Data Analysis.
Strong communication skills including written, verbal and listening skills.
Strong organizational skills, ability to multi-task and effectively prioritize your workload.
Proficient with Microsoft Office applications

Nice To Haves

experience with eQMS (Trackwise, EtQ) and ERP (SAP) software desired.

Responsibilities

Responsible for ensuring that activities performed at the Latham site comply with the requirements defined in Philips Excellence Process Framework (PEPF), Intra-Company Quality Agreements (ICQA) and additional applicable regulatory requirements.
Manage (local) QMS processes and ensure (local) process leveraging compliance capabilities.
Manage DHR review process.
Ensure Q&R requirements are effective in all processes in scope, Document Control management for all policies and local documentation.
Manage and monitor periodic documentation review process.
Ensure proper audit planning and schedule meets the requirements of internal policies and external regulations.
Supporting training and training administration as per the QMS and contributes to training content for local QMS documents as necessary.
Collection and reporting of metrics/KPI data to measure QMS effectiveness.