QMS Manager
Location: NetherlandsSIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
THE COMPANY
Our client is a professional Medical Devices organization, based in Noord-Brabant Netherlands.
ROLE DESCRIPTION
Manages the QMS transition of the PQMS/PEPF and manage its deployment in the Markets.
RESPONSIBILITIES
Locally manages plans for all QMS parts in scope while maintaining compliance and effectiveness throughout the duration of the transition to the PQMS. This includes the drafting of transition plans, execution of gap assessment against current QMS’s, action setting and follow-up on actions.
Ensures the addition and management of any local QMS documents are in line with the evolution of the PEPF and the PQMS.
Work with (Local) Business Process Owners, Business Process Experts, Market Deployment team, E2E Q&R and local Q&R in order to manage PEPF and PQMS deployments
Follows processes and operational policies in selecting methods and techniques for obtaining solutions
Manage document management activities for involved processes
Acts as advisor to subordinates to meet schedules and/or solve problems
REQUIREMENTS
• Experience working in disciplined regulated industry and in applying automated technology.
• Seasoned knowledge of ISO 9001 and ISO 13485 (preferable including ISO 9001:2015 and ISO 13485:2016)
• Strong analytic skills
• Demonstrated ability to understand and develop processes.
• Excellent organizational and Project management skills with an attention to detail and follow-through
• Professional English written and verbal communication skills
• Ability to influence others to achieving goals
• Ability to work under a minimum of supervision
• Hands-on mentality
• Minimum of five years of similar work experience.
• Has a complete knowledge of company products and services
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Rowin van der Zwaan.
