Quality Officer

QUALITY OFFICER

 

Our Story

Decades of shared passion for product innovation and entrepreneurship.
Oystershell – based in Ghent, Belgium – specializes in development and marketing of product innovations in dermatology, lice and insect treatments, and mineral supplements. Our mission is to develop and market the most effective, safe and convenient self-medication products to help people enjoy a healthy life.
At Oystershell, we have a talented cross-functional team with an entrepreneurial, performance-driven mindset. The employee population is very diverse, with over 10 nationalities and respect for gender equality.

Our Company’s Mission
Our mission is to develop and market the most effective, safe and convenient self-medication products to help people enjoy a healthy life.

Our company values are:
– Entrepreneurial and Creative Thinking
– Performance-Driven
– Collaborative Teamwork
– Respect for People
– Trust

YOUR ROLE
As a Quality Officer you have an interesting variety of tasks to support the Quality department.

Key responsibilities
– Prepare release of final product for Medical Devices & release of final products for non Medical Devices
– Support in follow up of quarterly batch record review for Medical Device CMO (contract manufacturing organization) + yearly verification of the analyses per CMO for Medical Devices
– Release article cards & bill of material (BOM) in our ERP system
– Support in dummy recall
– Release of all stock keeping items
– Calibration & verification of lab equipment at Oystershell laboratory
– Support Registration and reporting of non-recurrent complaints
– ’02 PRFI’s review van summary & underlying documents
– Set-up stability studies & perform in house analyses
– Support in change control, process validation & pilot batch production (admin, prep reports, follow up with CMO, …)
– Perform supplier audits
– Administrative support of the Quality Manager for the general CMO management (reports of recurrent meetings, follow up on action items, CAPA’s, …)

Required skills, educational and experience requirements
– Bachelor’s or Master’s Degree, preferably in sciences
– Proven experience in a role with a quality department
– Experience with medical devices (iso13485) is a very nice plus
– Microsoft Outlook, Word and Excel have no secrets for you
– Affinity with ERP/DMS packages is required
– Excellent knowledge of English. Dutch is a plus
– Soft skills:
– Accurate
– Respect deadlines
– Efficient
– Flexible
– Multi functional
– Stress resistant

Expected Professional Attitude
– You have a mature, positive personality and love challenges
– You are passionate and have strong organizational and administrative skills
– You work in an accurate and structured way
– You have a can-do & hands-on mentality
– Above all, you are a team player. Through your excellent communication skills, you ensure optimal cooperation within the company with all departments
It is our expectation that you live up to our quality standards as described in the quality policy. We expect you to take the necessary actions to comply with the quality objectives.

 

If you are interested in joining the dynamic team of Oystershell, please send your CV and motivation letter to hr@oystershell.be. Response and confidentiality are guaranteed.

Please note that we only accept direct applications.