Quality and Regulatory
SIRE
Noord-Brabant, Netherlands
12 dagen geleden

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

Part of the End 2 End program, the Quality System Business Process Expert supports the development, deployment and maintenance of the Quality Management System within Healthcare, ensuring cross sector harmonization, standardization and regulatory compliance.

You will ensure process compliance to regulations, and that optimization and efficiency are built into the Business Management and Quality Management System processes across all sectors and groups in partnership with the other business functions.

Responsibilities

  • Quality Management System Business Process Expert, acting in support of the Healthcare Quality Assurance team and Q&R Business Process Owner, across the Q&R network.
  • Participate directly as the Healthcare Quality Management System Business Process Expert in Process Capabilities deployment programs, in the Idea to Market, Market to Order, and / or Order to Cash arenas.
  • Ensuring compliance, efficiency and effectiveness of the processes within the Healthcare sector, cross sectors, and corporate.

  • This entails a thorough knowledge, as example, of Design, Marketing & Brand & Promotions, Production & Servicing and Procurement / Purchasing
  • Includes, but is not limited to all Idea to Market , Market to Order , and / or Order to Cash processes.
  • Support cross setup and deployment of the Quality Management Systems along business model lines as identified by End-to-
  • End teams through the creation of Quality Transition Plan(s) that identifies appropriate Q&R activities to ensure compliance.

  • Work with process modeling teams, Business Management System and Quality Management System owners, as well as any other stakeholders to ensure new process descriptions and procedures are efficient, effective, and compliant to the applicable regulations
  • Work with Software validation teams to ensure fully integrated, validated and compliant Integrated Landscape software application are deployed.
  • 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, including cross sector or business process standardization (desired), ensuring effectiveness and efficiency while maintaining compliance with worldwide regulations.
  • 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, JPAL, China GMP’s 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
  • Experience with deployment of Quality Management System processes as identified
  • Demonstrated practical knowledge in the selected domain
  • Skill set required for the department to operate :
  • Project management experience, desired
  • Good communication skills written & verbal in English
  • Software validation experience : understanding of high-level view of the requirements and supporting processes.
  • 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.
  • Experience understanding the process approach End-to-End’, where, the optimization of customer value chain starts from customer insight’ all the way to delivering products & service to the customers.
  • 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.

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