Our Client is a is an innovative medical device company based in Mont-Saint-Guibert with a production site located in the area of Liège that is currently developing a novel neurostimulation technology to treat Obstructive Sleep Apnea (OSA). The mission of the company is to provide their users, with the freedom to enjoy life to its fullest by delivering reliable, durable and harmonious solutions to treat OSA. They have an international scope with subsidiaries located in Irsaël and Australia.
You are looking for a professional challenge that allows you to work in a start-up environment in order to participate to the improvement of manufacturing activities in terms of Quality?
You want to bring your expertise in terms of GMP and/or ISO 13485 environment and/or Batch Release? You want to endorse polyvalent responsibilities in order to contribute to face a scaling-up phase?
Plus One can offer you this great challenge!
You will :
- Write and review of SOPs and other quality assurance related technical data forms and quality documents
- Support the Quality Manager in the process of Batch Release
- Manage CAPA’s, Deviation’s and Change Controls
- Ensure a proper maintenance of control documents in Quality Assurance;
- Control documents to different departments;
- Support the continuous improvement of company QMS, regarding production processes
- Assist in carrying out internal quality audits on company systems and documentations;
- Perform investigations on non-conformances and customer complaint close out and corrective actions;
- Ensure the timely and effective follow up to all identified or assigned quality issues;
- Communicate with production team and/or suppliers for quality issues
- Able to meet defined timelines and execution of tasks according to production priorities
- Observe and report any abnormal situation by initiating non-conformances report, provide support for the corresponding investigation
- Ensure additional missions in the field of her/his skills.
Professional skills Requirements:
- You own a Master or Bachelor Degree in technical of scientific fields.
- You have first experience (2-5 years) in Quality activities in Manufacturing environment.
- You have at least 2 years of experience with ISO 13 485 or in a highly regulated environment.
- You are able to communicate effectively with Production Team
- You are fluent in French and English (Verbal and non-verbal)
Personal skills required
- Proactive and good communicator.
- Ability to work independently while within a group framework
- Self-motivated, self-maintained and able to take the initiative to solve problems
- Good organization skills and hand’s on mindset
Our Client offers a full-time permanent position along with an attractive remuneration package.
This is an agile start-up company culture focused on values of entrepreneurship, engagement, integrity, passion and team spirit.
If you are interested in this challenging opportunity, please address your application (CV and short motivation text, both in English) to our recruitment partner, Plus One: Mrs. Gaëlle Minet, by email on email@example.com or apply directly on www.plusonesearch.be
Only selected candidates will be contacted.