QMS Manager

Location: Netherlands

SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences 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!Our client is a professional organisation, based in Noord-Brabant Netherlands.

Role Description

Quality Assurance is an integral aspect of the global healthcare business including device design, development, manufacture, distribution, worldwide device marketing, sales, service, and post-market surveillance. This position is intimately involved in the process of conducting Q&R Due Diligence Assessments for prospective M&A target companies.

Responsibilities

- Support the Mergers & Acquisitions team on assessing the regulatory and compliance gaps during due diligence phases, conduct Q&R Due Diligence
- Perform Assessments on prospective M&A target companies
- Co-ordinate (Project Manage) Revisions to the M&A Q&R Playbook
- Evaluate feedback from M&A Playbook Users in order to identify improvements to the M&A Q&R process
- Update M&A Q&R Playbook and associated Templates / Checklists, and M&A SharePoint as required
Deliver M&A Q&R process training to Q&R community
Coordinate and track M&A Q&R activities and progress as required
- Present on Progress to the Q&R Leadership Team as required

Requirements

- Bachelor’s degree or equivalent preferably in a scientific discipline
- Minimum of 7 years of experience working in Quality Assurance / Quality Engineering / Quality Systems supporting multiple functional disciplines within a global medical (device/Pharma) industry.
- Proven experience in Quality Management System processes.
- (Lead) auditor experience
- A comprehensive understanding of the diverse worldwide medical device quality regulations, including areas of device design, development, manufacture, distribution, worldwide device marketing, sales, service, and post-market surveillance.
- This position requires an extensive knowledge of FDA QSR’s, ISO 13485, and other worldwide Quality System Regulations.
- An ability to successfully communicate and educate Quality Management System regulations, policies and strategies to teams at all levels of the organization
- Skill set required for the department to operate:
- Project management experience, desired
- Good communication skills written & verbal in English
- Demonstrated experience in collaborative working environments
- Experience addressing conflicts, escalation at team level to achieve desired results.
- Demonstrated experience handling deadlines, able to focus on targets
- Demonstrated experience-driving progress, taking initiative to achieve results.

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Robin Hiariej.