QA Manager

Company Description

Exciting opportunity for a Quality Assurance Manager at Topcon Healthcare. Are you ready for the next step and do you want to contribute to optimal product quality and growth of the organization?Join Topcon, a company that has the ambition to make the world a better place at the intersection of eye healthcare andtechnology!

Topcon Healthcareis 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 groundbreaking 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.

Job Description

As a QA Manager, you ensure a high standard of product quality of Topcon’s products. You develop, implement and maintain QA and regulatory processes, while you ensure compliance by coordinating internal and external audits. You contribute to customer satisfaction by setting product quality standards and processes that align with customer expectations. You report to the QA/RA Director.

Your main responsibilities will be:

• planning, conducting, and managing internal and external product quality audits and inspections to assess compliance with product quality standards, identify non-conformities, evaluate supplier performance, and implement corrective actions as needed.
• assess and manage risks related to product quality, including product/process risks, regulatory risks, and supply chain risks. This includes developing risk management strategies, conducting risk assessments, and implementing risk mitigation measures.
• define, track, and analyze key quality metrics and performance indicators (KPIs) to measure the effectiveness of product quality processes, identify trends, and make data-driven decisions for improvement.
• support TEM RA in country registrations and interpretations of international regulations and with compliance related matters in relevant countries of sales.
  
  

create, manage, and maintain quality documentation, including quality manuals, standard operating procedures (SOPs), work instructions, audit reports, and other quality records, and environmental reporting on WEEE, packaging material, and batteries according to TEM procedures.

Qualifications

About you!

We are looking for an experienced finance professional with the following:

• a Master or PhD degree in Science or Engineering
• 5+ years experience with quality assurance of medical devices
• an excellent communicator and team player in an international and multi-stakeholder setting
• experience with standards and regulations such as ISO 9001, ISO 13485, FDA, EMA, GDPR
• fluent in English (written and spoken)
  
  

Additional Information

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.