Exciting opportunity for a Quality Management System Manager at Topcon Healthcare in Capelle aan den IJssel. Do you want to contribute by structuring and building optimal business processes and their compliance according to ISO standards and process controls (J-SOx)? Join Topcon, a company that has the ambition to make the world a better place at the intersection of eye healthcare and technology!

Topcon Healthcare is the eye health brand of Topcon Corporation (https://topconhealthcare.eu) Topcon Healthcare sees eye health differently. Our vision is to empower providers with smart and efficient technologies for enhanced patient care. Keeping pace with the ever-changing landscape of the healthcare industry, we offer the latest integrated solutions including advanced multimodal imaging, vendor-neutral data management and ground-breaking remote diagnostic technology. By investing in value-driven innovations, Topcon works to enable people to enjoy good health and a high quality of life.

Topcon Europe Medical B.V. is the EMEA headquarters and located in Capelle aan den Ijssel, The Netherlands. Topcon Europe Medical B.V. is responsible for the distribution, sales, service and development of the innovative products to different customers within the region.

You will lead the ambitious Business Process Control team, consisting of a QMS Specialist and an Internal Auditor J-Sox. This team is responsible for the design, improvement and compliance controls of the business processes within Topcon Healthcare in the EMEA region.

In this position you drive, guide and support business processes, ensuring that ISO relevant processes are correctly described and the required ISO certification is maintained within the EMEA region.

Through the correct identification, documentation of required actions and policies, conformity tests and continuous monitoring you and your team ensure that processes are continuously up to date. You will secure that the QMS is consistent and check the effectiveness of the QMS processes.

You have the following responsibilities:

• Monitor and follow up internal and external audit deficiencies and resolve them together with the relevant departments;
• Develop, implement, supervise and perform ISO and J-SOx audits in accordance with applicable procedures and standards;
• Audit projects, deliverables, operational processes, report findings, and drive improvement;
• Drive and manage the optimizations and improvements as a business partner;
• Support the execution of the process protocols;
• Develop and manage various operational (process) quality frameworks and tools (e.g. performance, tracking, scheduling, quality tools);
• Develop and manage procedures and systems to measure, analyze and report operational results;
• Identify and report opportunities for process improvement and development;
• Maintain an overview and solve the business issues at a detailed level;
• Inspire and motivate stakeholders involved to further integrate the processes.

About you!

A person who is excited by the unique professional challenges to optimize and structure processes. We are looking for a driver and executor who continuously strives for excellence structure and knows how to lead change. You are a self-starter, having organizational and analytical skills and are able to proactively and independently resolve issues in creative ways. You have a hands-on mentality and demonstrates resilience in challenging situations.

With your positive approach, you can inspire others to adopt the mentality of prioritizing quality above all else. Together with the team you always ensure optimal quality and improvement of processes. With your enthusiasm you make a positive contribution to this team. You have a proven track record in a similar role and qualifications as:

• Relevant university degree preferred combined with strong analytical skills;
• Easy to see through processes and an initiative-taking character;
• At least 5 years of experience in optimizing and improving processes in QMS in an international environment, including compliance management, preferably in a medical device or pharma company;
• Proven experience in leading auditing processes, incl. coordinating audits by external bodies;
• Experience in managing a (small) team;
• Experience with and full understanding of ISO 9001, ISO 14001 and preferably ISO 13485 and ISO 27001;
• You are accurate, detail oriented, process & structure driven and able to see the big picture (end-to-end approach);
• Proven ability to successfully incorporate and manage stakeholder needs throughout a project;
• Strong communication skills and able to maintain contacts at various levels in an international environment;
• Highly proficient in spoken and written English & Dutch.

What do we offer?

At Topcon we invest in you. We offer you an interesting, international work environment and varied position at a top player in the market. For this position we offer you a reward that, depending on knowledge and experience, can certainly be called excellent. In addition, we offer you an employment package, such as:

• Full employer paid pension contribution
• 13th month salary
• 28 vacation days

With a career at Topcon Healthcare, you have exciting new possibilities as we are improving human eye health through innovations in examination, diagnosis, and treatment. Especially today, due to rapid population growth, aging and mobile devise use, we see increased cases in eye conditions. As part of our team, you can contribute to continuously improving and accelerating (remote) diagnosis solutions.

Join Topcon!

This role is based in our office in Capelle aan den IJssel. Applicants without the right to work in the Netherlands won’t be considered.

Acquisition in response to our open vacancies will not be appreciated.