Quality Systems Specialist - 10 months contract

Responsibilities may include the following and other duties may be assigned: 

• Is the Subject Matter Expert for their Quality Systems such as Audits/Inspections, Change Control, Documentation, and Training. 

• Leads local improvement initiatives, acts as a game changer for his/her quality system. Contributes to global continuous improvement initiatives such as Enterprise Change Control, First Time Quality, Put Patient First or Quality Management System simplification.  

• Develops his/her network, showcases his/her achievements outside the site and brings best practices from others to the site.  

• Ensures process monitoring, reporting and improvement by providing leading KPIs for daily follow up and for Quality Management reviews. 

• Presents and defends their process during notified bodies audits and regulatory authorities’ inspections. Leads for their Quality system audit and inspection preparation, resolution of audit and inspection findings. 

• Collaborates with manufacturing, engineering, and development functions to ensure quality standards are in place.  

Required Knowledge and Experience: 

• Engineering bachelor’s degree minimum 

• Minimum of 2 years of relevant experience in medical device or pharmaceutical industry, within a manufacturing site 

• Fluent in French and English 

• Excellent communication skills and ability to work in a team environment as well as independently 

• A continuous improvement mindset 

• Exhibits high degree of initiative and good judgment. 

Nice to Haves 

• Root Cause investigations tools including DMAIC A3, 5 Whys, 6 M, Ishikawa Diagram and Pareto Charts 

• Project management