About our Client
Our client is a fast-growing, innovative and dynamic medical device company based in Wallonia.
To support their growth, they are looking for a Senior Quality Manager, who will lead overall quality responsibilities of Belgium and Europe activities.
The Senior QA Manager ensures EU and ISO quality and regulatory requirements are met for medical devices including product design and quality, supplier quality, manufacturing quality, audit management, and quality management systems.
He/she will work closely with cross-functional teams, employees and all stakeholders, internal and external.
The Sr. QA Manager will collaborate as a business partner while demonstrating expertise in body of knowledge for medical device quality requirements and its application. This position also works to develop quality strategies to support business growth.
Your role
• Ensure compliance to regulatory requirements including management of audits and inspections.
• Lead periodic quality management reviews for company as assigned.
• Lead Europe quality organization, conduct performance evaluations and build strong teams.
• Manage post-market surveillance and related activities such as complaints management and vigilance reporting.
• apply medical device requirements and ensure compliance to global standards (ISO 13485, US FDA QSR, MDSAP, ISO 14971, etc.)
• provide effective solutions and apply the quality requirements to help overall business and functional progress.
• Manage all quality related activities in respect to QMS including CAPA, design control, complaints, change control management, process control, and supplier management.
• Actively lead and /or participate in the preparation and execution of internal audits and external audits conducted by regulatory authorities.
• Assist in coordinating and documenting medical device reporting, post-market surveillance, recalls, and vigilance reporting and update appropriate regulatory agencies as required.
Your profile
• Bachelor or Master degree
• 5 years quality experience in Medical Device industry
• Solutions oriented with prudent decision making and risk assessment
• Outstanding people leadership skills along with able to be an effective business partner
• Have led external audits (FDA, Notified Body, Competent Authority)
• Effective communicator – clear, concise, articulate, active listening and able to convey key points
• Focused on actions and able to clearly deliver
• Good working knowledge of ISO 13485 guidelines, standards, GMP, QSR, MDR requirements.
• Ability to work well in cross-functional teams, independent yet passionate, good communication skills and a team player
• Analytical and data-driven
• Effective organizational skills
• Solid expertise in quality management system, and global regulations and standards.
• Able to work effectively in design quality, manufacturing quality, and supplier quality.
Our client's offer
Beyond a competitive salary and attractive benefits, our client offers you a challenging opportunity in an agile company.
Person in charge
Mélodie Dumoulin - Recruitment Consultant
Office : +32 010 39 21 83 / +32 475 63 39 28
Mail : mdumoulin@plusonesearch.be
